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ETB Trocar System

by The Altomec Corp.

510(k) K990894

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 NumberK990894 Date19 May 1999ClearedStatusActive

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  • Withdrawn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, 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 ETB Trocar System is a surgical instrument classified as a laparoscope under the General & Plastic Surgery category (product code GCJ). It is designed for creating access ports in minimally invasive procedures, facilitating the insertion of laparoscopic instruments into the abdominal cavity for diagnostic or therapeutic interventions.

This device is intended for single-use applications in sterile surgical settings, adhering to FDA 510(k) clearance (K990894) under the Traditional pathway. It is regulated for use in gastroenterology and urology procedures, with no explicit MRI safety or reusable specifications noted in the data. Storage and handling must comply with standard surgical instrument protocols.

Other devices from The Altomec Corp.