Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4590](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4590) → FBS — Sound, Metal, Interconnected

# FBS · Sound, Metal, Interconnected

_Gastroenterology, Urology · 21 CFR 876.4590 · Class 1_

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

## Overview

- **Product Code:** FBS
- **Device Name:** Sound, Metal, Interconnected
- **Regulation:** [21 CFR 876.4590](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4590)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## Identification

An interlocking urethral sound is a device that consists of two metal sounds (elongated instruments for exploring or sounding body cavities) with interlocking ends, such as with male and female threads or a rounded point and mating socket, used in the repair of a ruptured urethra. The device may include a protective cap to fit over the metal threads.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K954972](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FBS/K954972.md) | LYELL SOUND | Venture Management Corp. | Jan 24, 1996 | SESE |

## Top Applicants

- Venture Management Corp. — 1 clearance

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

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