Absorbable Surgical Gut Suture
Food and Drug Administration, HHS § 878.4840 § 878.4800 Manual surgical instrument in subpart E of part 807 of this chapter, for general use. subject to the limitations in § 878.9. (a) Identification. A manual surgical [53 FR 23872, June 24, 1988, as amended at 61 instrument for general use is a non- FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, powered, hand-held, or hand-manipu- 2001] lated device, either reusable or dispos- able, intended to be used in various § 878.4820 Surgical instrument motors general surgical procedures. The device and accessories/attachments. includes the applicator, clip applier, bi- (a) Identification. Surgical instrument opsy brush, manual dermabrasion motors and accessories are AC-pow- brush, scrub brush, cannula, ligature ered, battery-powered, or air-powered carrier, chisel, clamp, contractor, cu- devices intended for use during surgical rette, cutter, dissector, elevator, skin procedures to provide power to operate graft expander, file, forceps, gouge, in- various accessories or attachments to strument guide, needle guide, hammer, cut hard tissue or bone and soft tissue. hemostat, amputation hook, ligature Accessories or attachments may in- passing and knot-tying instrument, clude a bur, chisel (osteotome), knife, blood lancet, mallet, disposable dermabrasion brush, dermatome, drill or reusable aspiration and injection bit, hammerhead, pin driver, and saw needle, disposable or reusable suturing needle, osteotome, pliers, rasp, re- blade. tainer, retractor, saw, scalpel blade, (b) Classification. Class I (general con- scalpel handle, one-piece scalpel, snare, trols). The device is exempt from the spatula, stapler, disposable or reusable premarket notification procedures in stripper, stylet, suturing apparatus for subpart E of part 807 of this chapter the stomach and intestine, measuring subject to § 878.9.
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