Food and Drug Administration, HHS § 882.4325

§ 882.4150 Scalp clip. nervous tissue by the application of ex- (a) Identification. A scalp clip is a treme cold to the selected site. plastic or metal clip used to stop bleed- (b) Classification. Class II (perform- ing during on the scalp. ance standards). (b) Classification. Class II (perform- ance standards). § 882.4275 Dowel cutting instrument. (a) Identification. A dowel cutting in- § 882.4175 Aneurysm clip applier. strument is a device used to cut dowels (a) Identification. An aneurysm clip of bone for bone grafting. applier is a device used by the surgeon (b) Classification. Class II (perform- for holding and applying intracranial ance standards). aneurysm clips. (b) Classification. Class II (perform- § 882.4300 Manual cranial , burrs, ance standards). trephines, and their accessories (a) Identification. Manual cranial § 882.4190 Clip forming/cutting instru- drills, burrs, trephines, and their acces- ment. sories are bone cutting and drilling in- (a) Identification. A clip forming/cut- struments that are used without a ting instrument is a device used by the power source on a patient’s skull. physician to make tissue clips from (b) Classification. Class II (perform- wire stock. ance standards). (b) Classification. Class I. The device is exempt from the premarket notifica- § 882.4305 Powered compound cranial tion procedures in subpart E of part 807 drills, burrs, trephines, and their of this chapter. accessories. [44 FR 51730–51778, Sept. 4, 1979, as amended (a) Identification. Powered compound at 59 FR 63012, Dec. 7, 1994] cranial drills, burrs, trephines, and their accessories are bone cutting and § 882.4200 Clip removal instrument. drilling instruments used on a pa- (a) Identification. A clip removal in- tient’s skull. The instruments employ strument is a device used to remove a clutch mechanism to disengage the surgical clips from the patient. tip of the instrument after penetrating (b) Classification. Class I (general con- the skull to prevent plunging of the tip trols). The device is exempt from the into the brain. premarket notification procedures in (b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to the limitations in § 882.9. [44 FR 51730–51778, Sept. 4, 1979, as amended § 882.4310 Powered simple cranial at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July drills, burrs, trephines, and their 25, 2001] accessories. (a) Identification. Powered simple cra- § 882.4215 Clip rack. nial drills, burrs, trephines, and their (a) Identification. A clip rack is a de- accessories are bone cutting and - vice used to hold or store surgical clips ing instruments used on a patient’s during surgery. skull. The instruments are used with a (b) Classification. Class I (general con- power source but do not have a clutch trols). The device is exempt from the mechanism to disengage the tip after premarket notification procedures in penetrating the skull. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 882.9. ance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63012, Dec. § 882.4325 Cranial drill handpiece 7, 1994; 66 FR 38808, July 25, 2001] (brace). (a) Identification. A cranial drill hand- § 882.4250 Cryogenic surgical device. piece (brace) is a hand holder, which is (a) Identification. A cryogenic sur- used without a power source, for drills, gical device is a device used to destroy burrs, trephines, or other cutting tools nervous tissue or produce lesions in that are used on a patient’s skull.

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(b) Classification. Class I (general con- hold head and neck in a particular po- trols). The device is exempt from the sition during surgical procedures. premarket notification procedures in (b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to the limitations in § 882.9. [44 FR 51730–51778, Sept. 4, 1979, as amended § 882.4500 Cranioplasty material form- at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July ing instrument. 25, 2001] (a) Identification. A cranioplasty ma- terial forming instrument is a roller § 882.4360 Electric cranial drill motor. used in the preparation and forming of (a) Identification. An electric cranial cranioplasty (skull repair) materials. drill motor is an electrically operated (b) Classification. Class I (general con- power source used with removable ro- trols). The device is exempt from the tating surgical cutting tools or drill premarket notification procedures in bits on a patient’s skull. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 882.9. ance standards). [44 FR 51730–51778, Sept. 4, 1979, as amended § 882.4370 Pneumatic cranial drill at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July motor. 25, 2001] (a) Identification. A pneumatic cranial drill motor is a pneumatically operated § 882.4525 Microsurgical instrument. power source used with removable ro- (a) Identification. A microsurgical in- tating surgical cutting tools or drill strument is a nonpowered surgical in- bits on a patient’s skull. strument used in neurological micro- (b) Classification. Class II (perform- surgery procedures. ance standards). (b) Classification. Class I (general con- trols). The device is exempt from the § 882.4400 Radiofrequency lesion gen- erator. premarket notification procedures in subpart E of part 807 of this chapter (a) Identification. A radiofrequency le- subject to the limitations in § 882.9. sion generator is a device used to produce lesions in the nervous system [44 FR 51730–51778, Sept. 4, 1979, as amended or other tissue by the direct applica- at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July tion of radiofrequency currents to se- 25, 2001] lected sites. (b) Classification. Class II (perform- § 882.4535 Nonpowered neurosurgical ance standards). instrument. (a) Identification. A nonpowered § 882.4440 Neurosurgical headrests. neurosurgical instrument is a hand in- (a) Identification. A neurosurgical strument or an accessory to a hand in- headrest is a device used to support the strument used during neurosurgical patient’s head during a surgical proce- procedures to cut, hold, or manipulate dure. tissue. It includes specialized chisels, (b) Classification. Class I (general con- , , dissectors, ele- trols). The device is exempt from the vators, , gouges, hooks, surgical premarket notification procedures in knives, rasps, scissors, separators, subpart E of part 807 of this chapter spatulas, spoons, blades, blade holders, subject to the limitations in § 882.9. blade breakers, probes, etc. [44 FR 51730–51778, Sept. 4, 1979, as amended (b) Classification. Class I (general con- at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July trols). The device is exempt from the 25, 2001] premarket notification procedures in subpart E of part 807 of this chapter § 882.4460 Neurosurgical head holder subject to the limitations in § 882.9. (skull ). (a) Identification. A neurosurgical [44 FR 51730–51778, Sept. 4, 1979, as amended head holder (skull clamp) is a device at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July used to clamp the patient’s skull to 25, 2001]

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