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) → FFN — Clamp, Non-Electrical

# FFN · Clamp, Non-Electrical

_Gastroenterology, Urology · 21 CFR 876.4730 · Class 1_

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

## Overview

- **Product Code:** FFN
- **Device Name:** Clamp, Non-Electrical
- **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 |
| --- | --- | --- | --- | --- |
| [K932408](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN/K932408.md) | AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS | Baxter Healthcare Corp | Sep 28, 1993 | SESE |
| [K892550](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN/K892550.md) | BEST COLON CLAMP | Zinnanti Surgical Instruments, Inc. | May 9, 1989 | SESE |
| [K892542](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN/K892542.md) | RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU | Zinnanti Surgical Instruments, Inc. | May 9, 1989 | SESE |
| [K772405](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN/K772405.md) | TUBING CLAMP | Fred Sammons, Inc. | Jan 26, 1978 | SESE |
| [K771421](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FFN/K771421.md) | CATHETEO CLAMP | Quinton, Inc. | Oct 25, 1977 | SESE |

## Top Applicants

- Zinnanti Surgical Instruments, Inc. — 2 clearances
- Baxter Healthcare Corp — 1 clearance
- Fred Sammons, Inc. — 1 clearance
- Quinton, Inc. — 1 clearance

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

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