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Lap Wash System: Reuseable Lens Washer & Irrigating Sheath

by Devmed Group, Inc.

510(k) K953243

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 NumberK953243 Date28 Aug 1995ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

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

The Lap Wash System: Reusable Lens Washer & Irrigating Sheath is a medical device designed for use in endoscopic procedures to clean and irrigate lenses. It is classified under product code GCJ and was determined to be substantially equivalent to a predicate device through the FDA 510(k) process.

This device received FDA 510(k) clearance under K953243 on August 28, 1995, following a traditional review. It is manufactured by Devmed Group, Inc. and is intended for reuse in clinical settings, as indicated by its designation as a reusable lens washer and irrigating sheath.

Other devices from Devmed Group, Inc.

Questions

AI-generated answers, 6 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 Lap Wash System used for?

    The Lap Wash System is designed for use in endoscopic procedures to clean and irrigate lenses, as stated in its description. It functions as a reusable lens washer and irrigating sheath to maintain lens clarity during surgery.

  • Is the Lap Wash System reusable or single-use?

    The device is designated as reusable, as indicated by its name and description specifying it is a 'Reusable Lens Washer & Irrigating Sheath' intended for reuse in clinical settings.

  • What regulatory pathway was used for the Lap Wash System?

    The Lap Wash System received FDA 510(k) clearance under K953243 through a traditional review process, demonstrating substantial equivalence to a predicate device, as noted in the authorizations and decision details.

  • Who manufactures the Lap Wash System and where are they located?

    The Lap Wash System is manufactured by Devmed Group, Inc., located in Palm Beach Gardens, Florida, United States, as shown in the manufacturer and address fields.

  • What product code classifies the Lap Wash System?

    The device is classified under product code GCJ, which is specified in the specifications section and used to categorize the device for regulatory purposes.