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Modified Auto Suture Surgiport Premium Seal

by United States Surgical, A Division of Tyco Healthc

510(k) K925860

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 NumberK925860 Date23 Apr 1993ClearedStatusActive

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  • Withdrawn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.

This device is a modified auto suture Surgiport premium seal, classified as a laparoscope for general and plastic surgery under product code GCJ. It is a Class II medical device subject to special controls, designed for use in laparoscopic procedures to provide access to the abdominal cavity.

The device received FDA 510(k) clearance (K925860) on April 23, 1993, following a traditional review process. It was found substantially equivalent to a predicate device and submitted by United States Surgical, a division of Tyco Healthcare, located in Norwalk, Connecticut. The clearance is identified by the product code GCJ and advisory committee classification GU (Gastroenterology, Urology).

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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 Modified Auto Suture Surgiport Premium Seal used for?

    It is designed for use in laparoscopic procedures to provide access to the abdominal cavity, specifically indicated for general and plastic surgery applications as a laparoscope under product code GCJ.

  • How was the Modified Auto Suture Surgiport Premium Seal cleared for market?

    It received FDA 510(k) clearance (K925860) on April 23, 1993, through a traditional review process, after being found substantially equivalent to a predicate device.

  • Who manufactures the Modified Auto Suture Surgiport Premium Seal and where are they located?

    It is manufactured by United States Surgical, a division of Tyco Healthcare, located at 150 Glover Ave., Norwalk, Connecticut 06856, United States.