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Access Surgical Monopolar Endoscopic Surg. Instrum

by Access Surgical Intl., Inc.

510(k) K922425

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 NumberK922425 Date17 Nov 1992ClearedStatusActive

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 device is a monopolar endoscopic surgical instrument used in medical procedures. It includes various components such as an endoscope disinfectant basin, endoscopic magnetic retriever, sterile scissors for cystoscope, and disposable non-powered endoscopic grasping/cutting instruments.

The device is supplied in various forms and is intended for single use in general and plastic surgery settings. It received FDA 510(k) clearance on November 17, 1992, with the product code GEI. The device is manufactured by Access Surgical Intl., Inc. and is regulated as a class II medical device.

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Questions

AI-generated answers, 27 Sep 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 Access Surgical Monopolar Endoscopic Surgical Instrument used for?

    This device is a monopolar endoscopic surgical instrument used in medical procedures, specifically in general and plastic surgery settings. It includes various components such as an endoscope disinfectant basin, endoscopic magnetic retriever, sterile scissors for cystoscope, and disposable non-powered endoscopic grasping/cutting instruments.

  • Is this device single-use or reusable?

    The Access Surgical Monopolar Endoscopic Surgical Instrument is intended for single use only. It is supplied in various forms and should not be reused to ensure patient safety and maintain device integrity.

  • What regulatory approvals does this device have?

    The device received FDA 510(k) clearance on November 17, 1992, with the product code GEI. It is regulated as a class II medical device and was determined to be substantially equivalent to predicate devices.

  • Who manufactures this device and where is it produced?

    The Access Surgical Monopolar Endoscopic Surgical Instrument is manufactured by Access Surgical Intl., Inc. The company is located at 420 Rte. 206 N., Suite 200, Bedminster, NJ 07921, USA.