Flat Closed Wound Drain with Trocar

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K965146 ↗

FDA Product Code

GBX

Device Class

Class I

Regulation

21 CFR Part 878.4200

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Silicone Soft-Pak Epistaxis Catheter

  Class I

  FDA 510(k) K832476 Active Cleared 3 Nov 1983

• Axiom Atraum Trocar Catheter

  Class I

  FDA 510(k) K852241 Active Cleared 14 Jun 1985

• Axiom Feeding Gastro Tube

  Class II

  FDA 510(k) K831823 Active Cleared 12 Aug 1983

• Catheter Thoracic, Axiom

  Class II

  FDA 510(k) K770983 Active Cleared 29 Jul 1977

• Atraum Wound Dressing--Modification

  Class I

  FDA 510(k) K922760 Active Cleared 30 Oct 1992

• Disposable Fluid Collection Bag

  Class I

  FDA 510(k) K904133 Active Cleared 11 Oct 1990

See all devices from Axiom Medical, Inc. →