Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4730](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4730) → FFO — Retractor, Self-Retaining

# FFO · Retractor, Self-Retaining

_Gastroenterology, Urology · 21 CFR 876.4730 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFO

## Overview

- **Product Code:** FFO
- **Device Name:** Retractor, Self-Retaining
- **Regulation:** [21 CFR 876.4730](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4730)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K993544](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFO/K993544.md) | SPACE-OR RETRACTOR | Advanced Surgical Concepts (Asc) | Dec 22, 1999 | SESE |
| [K870897](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFO/K870897.md) | KODNER ANAL PERIONEAL RETRACTOR | Sur-Med Instruments, Inc. | Jun 4, 1987 | SESE |
| [K860368](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFO/K860368.md) | URDYN 5000 (UROFLOWMETER) | Dantec Electronics, Inc. | Apr 23, 1986 | SESE |
| [K853119](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFO/K853119.md) | URODYN 1000 | Dantec Electronics, Inc. | Oct 4, 1985 | SESE |
| [K852083](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFO/K852083.md) | THE KENDALL URINARY OUTPUT MONITOR | The Kendal Co. | Sep 20, 1985 | SESE |

## Top Applicants

- Dantec Electronics, Inc. — 2 clearances
- Advanced Surgical Concepts (Asc) — 1 clearance
- Sur-Med Instruments, Inc. — 1 clearance
- The Kendal Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFO](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFO)

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