Biofilm Trans. Pouch Ulcer & Wound Dressing

Q: What is the product code of K872101?

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

FDA 510(k) K872101 · The Bfgoodrich Co.

Substantially Equivalent for Some Indications

510(k) numberK872101

Submission

Device name: Biofilm Trans. Pouch Ulcer & 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

510(k)	Device	Applicant	Decision
K254246	LT Antibacterial Foam with Silver DressingNAD · Traditional	Zhejiang Longterm Medical Technology Co., Ltd.	09/10/2026SE
K102403	Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional	Sam Medical Products	03/03/2011SE
K091133	Aplion Topical Care SystemNAD · Traditional	Aplion Medical,Llc	05/20/2009SE
K072560	Envela (Hydrohesive Occlusive Dressing)NAD · Traditional	Teikoku Pharma USA, Inc.	06/17/2008SE
K080524	Centurion Sorbaview OTCNAD · Traditional	Tri-State Hospital Supply Corp.	04/23/2008SE
K060046	DermastreamNAD · Traditional	Enzysurge , Ltd.	02/27/2006SE
K043063	Oxyband Wound DressingNAD · Traditional	Oxyband Technologies, Inc.	03/24/2005SE
K020781	Wet ChamberNAD · Traditional	Kinetic Concepts, Inc.	05/06/2002SE
K990530	Kerlix MD Antimicrobial Gauze DressingNAD · Traditional	The Kendall Company, L.P.	01/31/2000SE
K990861	Wound Dressing/Abd Pad, Model #10810NAD · Traditional	Hospital Specialty Co.	04/12/1999SE

More from Hospital Specialty Co.

510(k)	Device	Decision
K875253	Bfgoodrich Biothane Non-Adherent DressingNAD · Traditional	04/13/1988SN
K872100	Biofilm Transorbent Ulcer and Wound DressingNAD · Traditional	06/30/1987SN
K872099	Biofilm Trans. Island, Island Ulcer & Wound Dress.NAD · Traditional	06/30/1987SN

Questions and answers

When was Biofilm Trans. Pouch Ulcer & Wound Dressing cleared by the FDA?

Biofilm Trans. Pouch Ulcer & Wound Dressing (K872101) 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 K872101?

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