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Bj Star All Silicone Foley Balloon Catheter

by B.J. Star, Inc. 510(k)

Active United States

510(k) K900022

Overview

The BJ STAR ALL SILICONE FOLEY BALLOON CATHETER is a medical device used in the treatment of gastrointestinal and urological disorders. Its all-silicone balloon design provides a durable and long-lasting solution for catheterization.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900022 Date15 Mar 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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