Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4770](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4770) → EZO — Urethrotome

# EZO · Urethrotome

_Gastroenterology, Urology · 21 CFR 876.4770 · Class 2_

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

## Overview

- **Product Code:** EZO
- **Device Name:** Urethrotome
- **Regulation:** [21 CFR 876.4770](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4770)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K000905](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K000905.md) | URETHROTOME 8667.XXX AND 8670.XXX | Richard Wolf Medical Instruments Corp. | May 12, 2000 | SESE |
| [K950719](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K950719.md) | OES UROLOGY | Olympus America, Inc. | Dec 11, 1996 | SESE |
| [K945686](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K945686.md) | KARL STORZ KNIVES, CURETTES | KARL STORZ Endoscopy-America, Inc. | Feb 13, 1995 | SESE |
| [K934730](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K934730.md) | KARL STORZ ENDOSCOPIC COLD KNIFE BLADES | KARL STORZ Endoscopy-America, Inc. | Jan 11, 1994 | SESE |
| [K904939](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K904939.md) | FLEXIBLE AND RIGID URETEROTOME SYSTEM | Olympus Corp. | Jan 7, 1992 | SESE |

## Top Applicants

- KARL STORZ Endoscopy-America, Inc. — 2 clearances
- Olympus America, Inc. — 1 clearance
- Olympus Corp. — 1 clearance
- Richard Wolf Medical Instruments Corp. — 1 clearance

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

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