§ 878.4780 21 CFR Ch. I (4–1–13 Edition)

§ 878.4780 Powered pump. to cut, destroy, or remove tissue by (a) Identification. A powered suction light energy emitted by carbon dioxide. pump is a portable, AC-powered or (2) An argon laser for use in derma- compressed air-powered device in- tology is a laser device intended to de- tended to be used to remove infectious stroy or coagulate tissue by light en- materials from wounds or fluids from a ergy emitted by argon. patient’s airway or respiratory support (b) Classification. (1) Class II. system. The device may be used during (2) Class I for special laser gas mix- in the operating room or at the tures used as a lasing medium for this patient’s bedside. The device may in- class of lasers. The devices subject to clude a microbial filter. this paragraph (b)(2) are exempt from (b) Classification. Class II. the premarket notification procedures § 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, , contractor, cu- devices intended for use during surgical rette, cutter, dissector, elevator, skin procedures to provide power to operate graft expander, file, , gouge, in- various accessories or attachments to strument guide, needle guide, hammer, cut hard tissue or bone and soft tissue. , amputation hook, ligature passing and knot-tying instrument, Accessories or attachments may in- knife, blood lancet, mallet, disposable clude a bur, chisel (), or reusable aspiration and injection dermabrasion brush, , needle, disposable or reusable suturing bit, hammerhead, pin driver, and saw needle, osteotome, pliers, rasp, re- blade. tainer, , saw, 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. tape, and calipers. A surgical instru- ment that has specialized uses in a spe- [55 FR 48440, Nov. 20, 1990, as amended at 65 cific medical specialty is classified in FR 2318, 2000] separate regulations in parts 868 § 878.4830 Absorbable surgical gut su- through 892. ture. (b) Classification. Class I (general con- trols). The device is exempt from the (a) Identification. An absorbable sur- premarket notification procedures in gical gut suture, both plain and chro- subpart E of part 807 of this chapter, mic, is an absorbable, sterile, flexible subject to the limitations in § 878.9. thread prepared from either the serosal connective tissue layer of beef (bovine) [53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, or the submucosal fibrous tissue of 1994; 66 FR 38803, July 25, 2001] sheep (ovine) intestine, and is intended for use in soft tissue approximation. § 878.4810 Laser surgical instrument (b) Classification. Class II (special for use in general and plastic sur- controls). The special control for this gery and in dermatology. device is FDA’s ‘‘Class II Special Con- (a) Identification. (1) A carbon dioxide trols Guidance Document: Surgical Su- laser for use in general surgery and in tures; Guidance for Industry and dermatology is a laser device intended

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