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Endopath EP Disposable Trocar

by Ethicon Inc.

510(k) K922608

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922608 Date12 Oct 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  • Withdrawn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
GCJ
FDA applicant
ETHICON, Inc.
Device class
Class II
Regulation
21 CFR Part 876.1500
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 Endopath EP Disposable Trocar is a surgical trocar classified under the nomenclature for devices providing access to body cavities, organs, or canals. It is designed for use in minimally invasive procedures to create a pathway for instruments, allowing entry into abdominal or pelvic cavities for diagnostic or therapeutic interventions.

This single-use device is intended for laparoscopic or endoscopic applications within the specialties of gastroenterology and urology. Supplied sterile and packaged for one-time use, it adheres to FDA 510(k) clearance (K922608) under product code GCJ, with regulatory classification as a Class II device. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

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