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21 CFR Ch. I (4–1–16 Edition)

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21 CFR Ch. I (4–1–16 Edition) § 878.4810 21 CFR Ch. I (4–1–16 Edition) needle, osteotome, pliers, rasp, re- (b) Classification. Class I (general con- tainer, retractor, saw, scalpel blade, trols). The device is exempt from the scalpel handle, one-piece scalpel, snare, premarket notification procedures in spatula, stapler, disposable or reusable subpart E of part 807 of this chapter stripper, stylet, suturing apparatus for subject to § 878.9. the stomach and intestine, measuring [55 FR 48440, Nov. 20, 1990, as amended at 65 tape, and calipers. A surgical instru- FR 2318, 2000] ment that has specialized uses in a spe- cific medical specialty is classified in § 878.4830 Absorbable surgical gut su- separate regulations in parts 868 ture. through 892. (a) Identification. An absorbable sur- (b) Classification. Class I (general con- gical gut suture, both plain and chro- trols). The device is exempt from the mic, is an absorbable, sterile, flexible premarket notification procedures in thread prepared from either the serosal subpart E of part 807 of this chapter, connective tissue layer of beef (bovine) subject to the limitations in § 878.9. or the submucosal fibrous tissue of [53 FR 23872, June 24, 1988, as amended at 54 sheep (ovine) intestine, and is intended FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, for use in soft tissue approximation. 1994; 66 FR 38803, July 25, 2001] (b) Classification. Class II (special controls). The special control for this § 878.4810 Laser surgical instrument device is FDA’s ‘‘Class II Special Con- for use in general and plastic sur- trols Guidance Document: Surgical Su- gery and in dermatology. tures; Guidance for Industry and (a) Identification. (1) A carbon dioxide FDA.’’ See § 878.1(e) for the availability laser for use in general surgery and in of this guidance document. dermatology is a laser device intended [54 FR 50738, Dec. 11, 1989, as amended at 68 to cut, destroy, or remove tissue by FR 32984, June 3, 2003] light energy emitted by carbon dioxide. (2) An argon laser for use in derma- § 878.4840 Absorbable polydioxanone tology is a laser device intended to de- surgical suture. stroy or coagulate tissue by light en- (a) Identification. An absorbable ergy emitted by argon. polydioxanone surgical suture is an ab- (b) Classification. (1) Class II. sorbable, flexible, sterile, (2) Class I for special laser gas mix- monofilament thread prepared from tures used as a lasing medium for this polyester polymer poly (p-dioxanone) class of lasers. The devices subject to and is intended for use in soft tissue this paragraph (b)(2) are exempt from approximation, including pediatric car- the premarket notification procedures diovascular tissue where growth is ex- in subpart E of part 807 of this chapter, pected to occur, and ophthalmic sur- subject to the limitations in § 878.9. gery. It may be coated or uncoated, undyed or dyed, and with or without a [53 FR 23872, June 24, 1988, as amended at 61 standard needle attached. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] (b) Classification. Class II (special controls). The special control for the § 878.4820 Surgical instrument motors device is FDA’s ‘‘Class II Special Con- and accessories/attachments. trols Guidance Document: Surgical Su- tures; Guidance for Industry and (a) Identification. Surgical instrument FDA.’’ See § 878.1(e) for the availability motors and accessories are AC-pow- of this guidance document. ered, battery-powered, or air-powered devices intended for use during surgical [67 FR 77676, Dec. 19, 2002] procedures to provide power to operate various accessories or attachments to § 878.4930 Suture retention device. cut hard tissue or bone and soft tissue. (a) Identification. A suture retention Accessories or attachments may in- device is a device, such as a retention clude a bur, chisel (osteotome), bridge, a surgical button, or a suture dermabrasion brush, dermatome, drill bolster, intended to aid wound healing bit, hammerhead, pin driver, and saw by distributing suture tension over a blade. larger area in the patient. 456 VerDate Sep<11>2014 17:25 Jun 08, 2016 Jkt 238077 PO 00000 Frm 00466 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB.
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