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Bardex Lubri-Sil I.C. Foley Catheter

by Bard Medical Div.

510(k) K984136

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK984136 Date16 Feb 1999ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-3116-2026 FDA Class II initiated 25 Jun 2026

    Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

    • Terminated Z-1144-03 FDA Unclassified (pre-2012) initiated 29 Aug 2002

    On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.

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  • Withdrawn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

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