C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 878—GENERAL AND PLASTIC SURGERY DEVICES › Subpart E—Surgical Devices

21 C.F.R. § 878.4800

Manual surgical instrument for general use

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(a) Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

[53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001; 86 FR 56204, Oct. 8, 2021; 86 FR 66188, Nov. 22, 2021]
Notes of Decisions
Cited in 2 cases, 1997–1997 · leading case: Coyne Beahm, Inc. v. United States Food & Drug Admin., 966 F. Supp. 1374 (M.D.N.C. 1997).
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Coyne Beahm, Inc. v. United States Food & Drug Admin., 966 F. Supp. 1374 (M.D.N.C. 1997). “4635 (ultraviolet lamps that deliver ultraviolet light which causes tanning); 21 C.F.R. § 878.4800 (surgical stapler that delivers staples that affect body tissues by holding them together); 21 C.”
Coyne Beahm, Inc. v. United States Food & Drug Admin., 958 F. Supp. 1060 (M.D.N.C. 1997). “4635 (ultraviolet lamps that deliver ultraviolet light which causes tanning); 21 C.F.R. § 878.4800 (surgical stapler that delivers staples that affect body tissues by holding them together); 21 C.”
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