Skip to content

Urinary Intermittent Catheters W/O Hydromer Hydrophilic Lubricant

by Biosearch Medical Products, Inc.

510(k) K951260

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 NumberK951260 Date27 Sep 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  • Withdrawn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
KOD
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Urinary intermittent catheters are medical devices used for bladder drainage in patients who cannot urinate naturally. They are primarily used by urologists and nurses in both hospital and home settings.

These catheters are supplied without hydromer hydrophilic lubricant and have FDA 510(k) clearance, K number K951260. They are classified as a class 2 device with the regulation number 876.5130.

Other devices from Biosearch Medical Products, Inc.

See all devices from Biosearch Medical Products, Inc. →