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ClickClean

by Medeon Biodesign, Inc.

510(k) K200902

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK200902 Date30 Apr 2020ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

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

ClickClean is a single-use, disposable laparoscopic cleaning device designed to maintain optical clarity of the laparoscope during minimally invasive procedures. It features a protective sheath that encases the laparoscope’s lens and is applied in situ to remove debris or fogging without requiring scope removal.

The device is intended for in-situ cleaning of laparoscopes during laparoscopic surgeries, ensuring continuous visual access for the surgeon. Supplied as a sterile, single-use item, it is classified under FDA 510(k) clearance (K200902) with a Special clearance type, adhering to regulatory standards for gastrointestinal and urological applications. No additional storage or preparation is required beyond standard sterile handling.

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

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