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Walther Catheters, Male, Female

by Thomasville Medical Assoc.

510(k) K926369

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 NumberK926369 Date21 May 1993ClearedStatusActive

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  • Withdrawn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
GBM
Device Class
Class II
Regulation
21 CFR Part 876.5130
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 Walther Catheters, Male and Female, are urethral catheters designed for urinary drainage. These devices are classified as Class II medical devices and are intended for temporary or intermittent catheterization to relieve urinary retention or facilitate bladder irrigation in clinical settings.

These catheters are supplied as single-use, sterile disposable devices and are regulated under FDA 510(k) clearance (K926369) with a determination of Substantially Equivalent. They are intended for use in urology and are available in multiple sizes and reference codes as listed in the regulatory submission. Storage and handling follow standard sterile medical device protocols.

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