← Product Code [EZO](/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO) · K000905

# URETHROTOME 8667.XXX AND 8670.XXX (K000905)

_Richard Wolf Medical Instruments Corp. · EZO · May 12, 2000 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K000905

## Device Facts

- **Applicant:** Richard Wolf Medical Instruments Corp.
- **Product Code:** [EZO](/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO.md)
- **Decision Date:** May 12, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.4770
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Regulatory Identification

A urethrotome is a device that is inserted into the urethra and used to cut urethral strictures and enlarge the urethra. It is a metal instrument equipped with a dorsal-fin cutting blade which can be elevated from its sheath. Some urethrotomes incorporate an optical channel for visual control.

## Special Controls

*Classification.* Class II (special 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.

---

**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K000905](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K000905)

**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