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Karl Storz Adapters for Documentation Purposes

by Karl Storz Endoscopy-America, Inc.

510(k) K950336

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 NumberK950336 Date13 Feb 1995ClearedStatusActive

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

Karl Storz Adapters for Documentation Purposes are endoscopic accessories designed for use with endoscopes to facilitate documentation during procedures. They are classified under product code GCJ as laparoscopes for general and plastic surgery applications.

These adapters are supplied as reusable devices and were granted FDA 510(k) clearance K950336 on February 13, 1995, as substantially equivalent to a predicate device. They are intended for use in endoscopic procedures within the specialties of gastroenterology and urology, as indicated by the advisory committee review.

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