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Ksea Sialoendoscopes And Accessories

by Karl Storz Endoscopy-America, Inc.

510(k) K012527

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 NumberK012527 Date1 Nov 2001ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

The Ksea Sialoendoscopes And Accessories are medical devices used in endoscopy procedures. They are designed for use in gastroenterology and urology applications. The device type is classified under the product code GCJ.

The Ksea Sialoendoscopes And Accessories are supplied by Karl Storz Endoscopy-America, Inc. and have received FDA 510K clearance, with the clearance number K012527. The device is intended for use in medical settings, with specific storage and handling requirements not specified in the provided data.

Other devices from Karl Storz Endoscopy-America, Inc.

See all devices from Karl Storz Endoscopy-America, Inc. →

Questions

AI-generated answers, 26 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 are Ksea Sialoendoscopes used for?

    Ksea Sialoendoscopes are used in endoscopy procedures for gastroenterology and urology applications, providing visualization in medical settings.

  • Are Ksea Sialoendoscopes supplied sterile?

    The provided data does not specify the sterility of Ksea Sialoendoscopes, so handling and storage should follow standard medical device protocols.

  • What is the regulatory status of Ksea Sialoendoscopes?

    Ksea Sialoendoscopes have received FDA 510K clearance with the clearance number K012527, indicating they are substantially equivalent to a predicate device.