FFO · Retractor, Self-Retaining
Gastroenterology, Urology · 21 CFR 876.4730 · Class 1
Overview
| Product Code | FFO |
|---|---|
| Device Name | Retractor, Self-Retaining |
| Regulation | 21 CFR 876.4730 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K993544 | SPACE-OR RETRACTOR | Advanced Surgical Concepts (Asc) | Dec 22, 1999 | SESE |
| K870897 | KODNER ANAL PERIONEAL RETRACTOR | Sur-Med Instruments, Inc. | Jun 4, 1987 | SESE |
| K860368 | URDYN 5000 (UROFLOWMETER) | Dantec Electronics, Inc. | Apr 23, 1986 | SESE |
| K853119 | URODYN 1000 | Dantec Electronics, Inc. | Oct 4, 1985 | SESE |
| K852083 | THE KENDALL URINARY OUTPUT MONITOR | The Kendal Co. | Sep 20, 1985 | SESE |
Top Applicants
- Dantec Electronics, Inc. — 2 clearances
- The Kendal Co. — 1 clearance
- Sur-Med Instruments, Inc. — 1 clearance
- Advanced Surgical Concepts (Asc) — 1 clearance
