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CleverLock Guidewire Locking Device and Biopsy Cap

by Olympus Surgical Technologies America

510(k) K190164

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 NumberK190164 Date4 Apr 2019ClearedStatusActive

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  • Withdrawn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
ODC
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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 CleverLock Guidewire Locking Device and Biopsy Cap is an endoscope channel accessory designed to secure guidewires during endoscopic procedures. It functions as a combination locking device and biopsy valve to hold guidewires in place while preventing the reflux of body fluids.

This device is intended for use with endoscopic equipment in settings such as gastroenterology and urology. It is designed for integration with endoscopes to facilitate the management of EndoTherapy devices during procedures like ERCP.

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