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Karl Storz Endoscopic Cold Knife Blades

by Karl Storz Endoscopy-America, Inc.

510(k) K934730

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934730 Date11 Jan 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EZO
Device Class
Class II
Regulation
21 CFR Part 876.4770
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a urethrotome, specifically Karl Storz Endoscopic Cold Knife Blades, classified under product code EZO and device class II. It is a surgical instrument designed for endoscopic urethrotomy procedures.

The device is supplied as a single-use, sterile blade intended for use in gastroenterology and urology settings. It received FDA 510(k) clearance (K934730) on January 11, 1994, as substantially equivalent to a predicate device, and is subject to special controls for urethrotomes.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Karl Storz Endoscopic Cold Knife Blade used for?

    It is a surgical instrument designed for endoscopic urethrotomy procedures, specifically to cut urethral strictures under direct vision during urological or gastroenterological interventions.

  • Is the Karl Storz Endoscopic Cold Knife Blade sterile and single-use?

    Yes, the device is supplied as a single-use, sterile blade, meaning it is intended for one procedure only and must be discarded after use to prevent cross-contamination and ensure patient safety.

  • What regulatory pathway was used for the Karl Storz Endoscopic Cold Knife Blade?

    The device received FDA 510(k) clearance (K934730) on January 11, 1994, as substantially equivalent to a legally marketed predicate device, and is classified as a Class II medical device under product code EZO.