Ulcer Wound Tray

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K922828 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SEKD

• Absorbent Fiber

  Class I

  FDA 510(k) K914431 Active Cleared 4 Dec 1991

• Surgical Instrument Kit, Disposable

  Class I

  FDA 510(k) K920989 Active Cleared 19 Oct 1992

• Absorbable Gauze Drape

  Class II

  FDA 510(k) K901465 Active Cleared 12 Jun 1990

• Ulticare Safety Insulin Syringe

  Class II

  FDA 510(k) K103011 Active Cleared 2 Feb 2011

• Post Operative Sponge

  Class I

  FDA 510(k) K912693 Active Cleared 4 Oct 1991

• Cover, Shoe Operating Room

  Class I

  FDA 510(k) K865023 Active Cleared 12 Jan 1987

See all devices from Ulti-Med Intl., Inc. →

• What is the ulcer wound tray used for?

  The ulcer wound tray is designed for the management and treatment of ulcers and wounds, supporting clinical procedures by providing a contained system to organize and use associated wound care materials in general and plastic surgery environments.

• Is the ulcer wound tray sterile when supplied?

  The ulcer wound tray is provided non-sterile and must be sterilized prior to use, as it is a single-use device intended for clinical settings where sterility is required for wound care procedures.

• How is the ulcer wound tray supplied and what is its intended use duration?

  The device is supplied as a tray and is intended for single-use only, meaning it should be used once and then discarded after the wound care procedure is completed.

• What regulatory pathway was used for the ulcer wound tray?

  The ulcer wound tray received FDA 510(k) clearance under submission K922828, with product code KKX, and was cleared on September 28, 1992, for its intended use in wound care management.