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Surgiquest Elastomeric Optical Trocar & Cannula

by Surgiquest, Inc.

510(k) K063859

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 NumberK063859 Date14 Mar 2007ClearedStatusActive

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  • Withdrawn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, 25 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 Surgiquest Elastomeric Optical Trocar & Cannula is a device designed for use in abdominal and thoracic minimally invasive surgical procedures. It establishes a path of entry for endoscopic instruments, facilitating access during surgical interventions.

The device is supplied as a disposable endoscopic optical trocar and cannula kit. It is intended for single-use applications and is not reusable. The device is not MRI safe, and no specific storage conditions are provided in the specifications.

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