CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 876—GASTROENTEROLOGY-UROLOGY DEVICES > SUBPART E—Surgical Devices (§876.4020 to §876.4890) > 876.4730—Manual gastroenterology-urology surgical instrument and accessories.

876.4730—Manual gastroenterology-urology surgical instrument and accessories.

(a) Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.
(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 § 876.9.

Code of Federal Regulations

[48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 66 FR 38801, July 25, 2001]