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Aesculap Trocar Instrument Set

by Aesculap, Inc. 3 variants

510(k) K934724

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK934724 Date23 Dec 1993ClearedStatusActive

Official records

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  • Withdrawn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
FBQ
Device class
Class II
Regulation
21 CFR Part 876.5090
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Aesculap Trocar Instrument Set is a trocar device used in gastroenterology and urology procedures. It is a reusable surgical instrument set designed for general and visceral surgery, ear-nose-throat surgery, and maxillo-facial surgery applications.

The device is supplied non-sterile ex works and requires sterilization prior to use. It is a reusable system with UDI direct marking and is classified as a Class II medical device under FDA 510(k) clearance K934724. The set includes multiple tip configurations and is intended for use in surgical settings where trocar access is required.

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