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Absorbable Surgical Gut Suture

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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. tape, and calipers. A surgical instru- [55 FR 48440, Nov. 20, 1990, as amended at 65 ment that has specialized uses in a spe- FR 2318, 2000] cific medical specialty is classified in separate regulations in parts 868 § 878.4830 Absorbable surgical gut su- through 892. ture. (b) Classification. Class I (general con- (a) Identification. An absorbable sur- trols). The device is exempt from the gical gut suture, both plain and chro- premarket notification procedures in mic, is an absorbable, sterile, flexible subpart E of part 807 of this chapter, thread prepared from either the serosal subject to the limitations in § 878.9. connective tissue layer of beef (bovine) [53 FR 23872, June 24, 1988, as amended at 54 or the submucosal fibrous tissue of FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, sheep (ovine) intestine, and is intended 1994; 66 FR 38803, July 25, 2001] for use in soft tissue approximation. (b) Classification. Class II (special § 878.4810 Laser surgical instrument 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- trols Guidance Document: Surgical Su- (a) Identification. (1) A carbon dioxide tures; Guidance for Industry and laser for use in general surgery and in FDA.’’ See § 878.1(e) for the availability dermatology is a laser device intended of this guidance document. to cut, destroy, or remove tissue by light energy emitted by carbon dioxide. [54 FR 50738, Dec. 11, 1989, as amended at 68 (2) An argon laser for use in derma- FR 32984, June 3, 2003] tology is a laser device intended to de- stroy or coagulate tissue by light en- § 878.4840 Absorbable polydioxanone ergy emitted by argon. surgical suture. (b) Classification. (1) Class II. (a) Identification. An absorbable (2) Class I for special laser gas mix- polydioxanone surgical suture is an ab- tures used as a lasing medium for this sorbable, flexible, sterile, class of lasers. The devices subject to monofilament thread prepared from this paragraph (b)(2) are exempt from polyester polymer poly (p-dioxanone) the premarket notification procedures and is intended for use in soft tissue 443 VerDate Mar<15>2010 18:43 May 19, 2014 Jkt 232077 PO 00000 Frm 00453 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT ofr150 PsN: PC150.
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