Biofilm Transorbent Ulcer and Wound Dressing

FDA 510(k) K872100 · The Bfgoodrich Co.

Substantially Equivalent for Some Indications

510(k) numberK872100

Submission

Device name
Biofilm Transorbent Ulcer and Wound Dressing
Applicant
The Bfgoodrich Co.
Brecksville, OH, US
Received
June 1, 1987
Decision date
June 30, 1987
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
NAD – Dressing, Wound, Occlusive
Device class
Class I (low risk)
Regulation
21 CFR 878.4020
Specialty
General, Plastic Surgery

Other 510(k)s with product code NAD

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K254246LT Antibacterial Foam with Silver DressingNAD · Traditional Zhejiang Longterm Medical Technology Co., Ltd.09/10/2026SE
K102403Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional Sam Medical Products03/03/2011SE
K091133Aplion Topical Care SystemNAD · Traditional Aplion Medical,Llc05/20/2009SE
K072560Envela (Hydrohesive Occlusive Dressing)NAD · Traditional Teikoku Pharma USA, Inc.06/17/2008SE
K080524Centurion Sorbaview OTCNAD · Traditional Tri-State Hospital Supply Corp.04/23/2008SE
K060046DermastreamNAD · Traditional Enzysurge , Ltd.02/27/2006SE
K043063Oxyband Wound DressingNAD · Traditional Oxyband Technologies, Inc.03/24/2005SE
K020781Wet ChamberNAD · Traditional Kinetic Concepts, Inc.05/06/2002SE
K990530Kerlix MD Antimicrobial Gauze DressingNAD · Traditional The Kendall Company, L.P.01/31/2000SE
K990861Wound Dressing/Abd Pad, Model #10810NAD · Traditional Hospital Specialty Co.04/12/1999SE

More from Hospital Specialty Co.

510(k)DeviceDecision
K875253Bfgoodrich Biothane Non-Adherent DressingNAD · Traditional 04/13/1988SN
K872101Biofilm Trans. Pouch Ulcer & Wound DressingNAD · Traditional 06/30/1987SN
K872099Biofilm Trans. Island, Island Ulcer & Wound Dress.NAD · Traditional 06/30/1987SN

Questions and answers

When was Biofilm Transorbent Ulcer and Wound Dressing cleared by the FDA?

Biofilm Transorbent Ulcer and Wound Dressing (K872100) received a 510(k) decision of Substantially Equivalent for Some Indications on June 30, 1987, 29 days after the submission was received.

What is the product code of K872100?

The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.