Skip to content

Tls Bulb Drainage System

by Porex Medical

510(k) K833586

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK833586 Date30 Jan 1984ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1150-2017 FDA Class II initiated 3 Jan 2017
    • Terminated Z-1149-2017 FDA Class II initiated 3 Jan 2017

    An incorrect sterility status on the label, non-sterile products labeled as sterile

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  • Withdrawn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
GCY
Device Class
Class I
Regulation
21 CFR Part 878.4680
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Other devices from Porex Medical

See all devices from Porex Medical →