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) → FKK — Clamp, Line

# FKK · Clamp, Line

_Gastroenterology, Urology · 21 CFR 876.4730 · Class 1_

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

## Overview

- **Product Code:** FKK
- **Device Name:** Clamp, Line
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K854517](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FKK/K854517.md) | NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET | Travenol Laboratories, S.A. | Dec 2, 1985 | SESE |
| [K854512](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FKK/K854512.md) | TUBING CLAMP CAT#1000-A | Rao Medical Devices, Inc. | Dec 2, 1985 | SESE |
| [K844121](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FKK/K844121.md) | CLAMP, TUBING, LINE | Dyn-A-Med Products | Dec 17, 1984 | SESE |
| [K831689](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FKK/K831689.md) | EMPTY DIALYSATE CONTAINER | Delmed, Inc. | Aug 11, 1983 | SESE |
| [K822551](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FKK/K822551.md) | AMP CAPD UNISPIKE AMINISTRATION SET | American Medical Products, Inc. | Oct 13, 1982 | SESE |
| [K802009](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FKK/K802009.md) | FLOWCLAMP CAT.#1011 & 1012 | Pollak (Intl.), Ltd. | Oct 31, 1980 | SESE |

## Top Applicants

- American Medical Products, Inc. — 1 clearance
- Delmed, Inc. — 1 clearance
- Dyn-A-Med Products — 1 clearance
- Pollak (Intl.), Ltd. — 1 clearance
- Rao Medical Devices, Inc. — 1 clearance

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

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