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ENDOTACK

by Karl Storz Endoscopy-America, Inc.

510(k) K022853

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 NumberK022853 Date25 Nov 2002ClearedStatusActive

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  • Withdrawn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
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

ENDOTACK is a medical device classified under product code MBI, which is related to orthopedic applications. The device is manufactured by KARL STORZ Endoscopy-America, Inc. and received FDA 510(k) clearance with the K number K022853 on November 25, 2002.

ENDOTACK is supplied as a single-use device and is not intended for MRI environments. It is stored at room temperature and requires no special handling. The device is authorized for use in the United States under FDA 510(k) clearance.

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Questions

AI-generated answers, 27 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 ENDOTACK device used for?

    ENDOTACK is a medical device classified under product code MBI, specifically designed for orthopedic applications. It is manufactured by KARL STORZ Endoscopy-America, Inc. and has received FDA 510(k) clearance for use in the United States.

  • Is the ENDOTACK device reusable or single-use?

    The ENDOTACK device is supplied as a single-use device and is not intended for reuse. This design ensures sterility and prevents cross-contamination between patients.

  • What are the storage requirements for the ENDOTACK device?

    ENDOTACK is stored at room temperature and requires no special handling. This makes it convenient for clinical settings without the need for specialized storage conditions.

  • What regulatory clearance does the ENDOTACK device have?

    ENDOTACK has received FDA 510(k) clearance with the K number K022853 on November 25, 2002. It is authorized for use in the United States under this clearance.