21 CFR Ch. I (4–1–08 Edition)

§ 882.4360 21 CFR Ch. I (4–1–08 Edition)

(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 material 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 generator. 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- osteotomes, curettes, dissectors, ele- trols). The device is exempt from the vators, forceps, 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 clamp). (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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