← Product Code [EZO](/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO) · K934730

# KARL STORZ ENDOSCOPIC COLD KNIFE BLADES (K934730)

_KARL STORZ Endoscopy-America, Inc. · EZO · Jan 11, 1994 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K934730

## Device Facts

- **Applicant:** KARL STORZ Endoscopy-America, Inc.
- **Product Code:** [EZO](/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO.md)
- **Decision Date:** Jan 11, 1994
- **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.

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K934730](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/EZO/K934730)

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