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Watts Rake with Leur Lock Port

by Phx Technologies Corp.

510(k) K934153

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 NumberK934153 Date18 Mar 1994ClearedStatusActive

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  • Withdrawn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, 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.

The Watts Rake With Luer Lock Port is a diagnostic device classified under the product code GCJ, designed for use in endoscopic procedures. It features a rake configuration with a built-in Luer Lock port, enabling fluid aspiration or irrigation during gastrointestinal or urological examinations.

This device is intended for single-use and requires FDA 510(k) clearance (K934153) as a substantially equivalent product, approved under the Traditional 510(k) review pathway. Supplied sterile, it is used in controlled clinical settings such as endoscopy suites and is regulated under the advisory committee for Gastroenterology and Urology. Storage and handling must comply with sterile medical device protocols.

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