FLOWCLAMP CAT.#1011 & 1012
Device Facts
| Record ID | K802009 |
|---|---|
| Device Name | FLOWCLAMP CAT.#1011 & 1012 |
| Applicant | Pollak (Intl.), Ltd. |
| Product Code | FKK · Gastroenterology, Urology |
| Decision Date | Oct 31, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4730 |
| Device Class | Class 1 |
Regulatory Classification
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.
