21 CFR 876.4730 — Probe, Rectal, Non-Powered
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4730
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. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EXX | Probe, Rectal, Non-Powered | 1 | 0 | |
| FCH | Tray, Biopsy, Without Biopsy Instruments | 1 | 2 | |
| FFN | Clamp, Non-Electrical | 1 | 5 | |
| FFO | Retractor, Self-Retaining | 1 | 5 | |
| FFQ | Speculum, Rectal | 1 | 1 | |
| FFR | Device, Locking, For Intestinal Clamp | 1 | 0 | |
| FGM | Probe And Director, Gastro-Urology | 1 | 7 | |
| FGN | Retractor, Non-Self-Retaining | 1 | 0 | |
| FGX | Snare, Non-Electrical | 1 | 0 | |
| FHB | Hook, Gastro-Urology | 1 | 0 | |
| FHH | Crusher, Spur, Colostomy | 1 | 0 | |
| FHI | Ring, Laparotomy | 1 | 0 | |
| FHK | Spreader, Bladder Neck | 1 | 0 | |
| FHL | Scoop | 1 | 0 | |
| FHQ | Holder, Needle, Gastroenterologic | 1 | 7 | |
| FKK | Clamp, Line | 1 | 6 | |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | 1 | 44 | |
| OLH | Orchidometer | 1 | 0 | |
| OOW | Applicator For Rectal Suppository | 1 | 1 | |
| PVY | Vasovasostomy Set | 1 | 0 |
