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Portland Trocars

by Surgical Innovations Plc

510(k) K962193

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 NumberK962193 Date28 Aug 1996ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

Portland Trocars are a laparoscope device classified under the product code GCJ for general and plastic surgery. They are substantially equivalent to a legally marketed device as determined by FDA 510(k) clearance.

The device was cleared by the FDA on August 28, 1996, under traditional 510(k) review, with submission received on June 7, 1996. It is classified as Class II with special controls and was reviewed by the Gastroenterology and Urology advisory committee.

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Questions

AI-generated answers, 1 Oct 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 Portland Trocars device used for?

    The Portland Trocars are a laparoscope device intended for use in general and plastic surgery procedures, as indicated by their classification under product code GCJ.

  • When was the Portland Trocars device cleared by the FDA?

    The Portland Trocars device received FDA 510(k) clearance on August 28, 1996, following a traditional review process with submission received on June 7, 1996.

  • What regulatory pathway was used for the Portland Trocars device?

    The Portland Trocars device was cleared through the FDA's traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device.

  • Which advisory committee reviewed the Portland Trocars device?

    The Portland Trocars device was reviewed by the Gastroenterology and Urology advisory committee during its FDA 510(k) submission process.