Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5160](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5160) → FHA — Clamp, Penile

# FHA · Clamp, Penile

_Gastroenterology, Urology · 21 CFR 876.5160 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA

## Overview

- **Product Code:** FHA
- **Device Name:** Clamp, Penile
- **Regulation:** [21 CFR 876.5160](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5160)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.

## Classification Rationale

Class I (general controls). Except when intended for internal use, 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K974040](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K974040.md) | C3 EXTERNAL MALE BLADDER CONTROL DEVICE | Timm Research Co. | Jul 14, 1998 | SESE |
| [K971992](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K971992.md) | UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026) | Uromed Corp. | Aug 1, 1997 | SESE |
| [K970308](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K970308.md) | MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE | Mentor Urology, Inc. | Apr 2, 1997 | SESE |
| [K964580](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K964580.md) | CAP-AID (IMPROVED) | Nebel, Inc. | Jan 10, 1997 | SESE |
| [K955810](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K955810.md) | U-TEX | Laborie Medical Technologies, Ltd. | Jan 24, 1996 | SESE |
| [K954959](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K954959.md) | CAP-AID | Nebl, Inc. | Dec 6, 1995 | SESE |
| [K952841](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K952841.md) | THE ASSISTANT | Apple Medical Corp. | Aug 18, 1995 | SESE |
| [K896160](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K896160.md) | WILLIAMS PENILE ANESTHETIC RETAINER | Cook Urological, Inc. | Feb 16, 1990 | SESE |
| [K885323](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K885323.md) | DACOMED EXTERNAL MALE CONTINENCE DEVICE | Dacomed Corp. | Feb 8, 1989 | SESE |
| [K863227](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K863227.md) | COOK-VPI CONTINENCE CUFF | Cook Urological, Inc. | Feb 3, 1987 | SESE |
| [K780137](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA/K780137.md) | CLAMP, INCONTINENCE, BAUMRUCKER | Greenwald Surgical Co., Inc. | Apr 28, 1978 | SESE |

## Top Applicants

- Cook Urological, Inc. — 2 clearances
- Apple Medical Corp. — 1 clearance
- Dacomed Corp. — 1 clearance
- Greenwald Surgical Co., Inc. — 1 clearance
- Laborie Medical Technologies, Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FHA)

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