← Product Code [FBS](/submissions/GU/subpart-e%E2%80%94surgical-devices/FBS) · K954972

# LYELL SOUND (K954972)

_Venture Management Corp. · FBS · Jan 24, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FBS/K954972

## Device Facts

- **Applicant:** Venture Management Corp.
- **Product Code:** [FBS](/submissions/GU/subpart-e%E2%80%94surgical-devices/FBS.md)
- **Decision Date:** Jan 24, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4590
- **Device Class:** Class 1
- **Review Panel:** Gastroenterology, Urology

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FBS/K954972](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FBS/K954972)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com