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Uro-Baggie

by Cwt Workshop 510(k)

Active United States

510(k) K895168

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895168 Date22 Mar 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
KNX
Device Class
Class II
Regulation
21 CFR Part 876.5250
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent