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External Male Catheter

by Buffalo Medical Specialties Mfg., Inc. 510(k)

Active United States

510(k) K852051

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852051 Date22 Aug 1985ClearedStatusActive

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  • Withdrawn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
KNX
Device Class
Class II
Regulation
21 CFR Part 876.5250
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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