A-Sorb

FDA 510(k) K882115 · Howard Medical Co.

Substantially Equivalent

510(k) numberK882115

Submission

Device name
A-Sorb
Applicant
Howard Medical Co.
Chicago, IL, US
Received
May 19, 1988
Decision date
October 3, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
NAB – Gauze / Sponge,Nonresorbable For External Use
Device class
Class I (low risk)
Regulation
21 CFR 878.4014
Specialty
General, Plastic Surgery

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K946015Ivalon External SpongeNAB · Traditional Ivalon02/27/1995SE
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K931610Omnisorb II, Nonwoven Sponge, Sterile and NonNAB · Traditional Omni Mfg., Inc.06/24/1993SE
K925590Multi-Trauma DressingNAB · Traditional Gam Industries, Inc.04/08/1993SE
K926072K-Band and K-CrepeNAB · Traditional Parema , Ltd.03/19/1993SE
K915591Sterile Gauze PadsNAB · Traditional Eagle Medical, Inc.01/27/1993SE
K924650Gauze SpongesNAB · Traditional Dav-Mar Medical Products, Inc.01/11/1993SE
K923602Absorbent Pad -- ModificationNAB · Traditional Winfield Laboratories, Inc.12/07/1992SE
K923115ClinisorbNAB · Traditional Hermitage Hospital Products, Inc.11/23/1992SE
K923378Usp Type Vii Gauze SpongesNAB · Traditional E.W.A., Ltd.10/06/1992SE

More from E.W.A., Ltd.

510(k)DeviceDecision
K962234Sterile Gauze Sponge - Pick-Ups 12PLY (GS-412), Pick-Ups 16PLY (GS-416)EFQ · Traditional 06/28/1996SE
K820195Or Specialties Vaginal PackEFQ · Traditional 03/05/1982SE

Questions and answers

When was A-Sorb cleared by the FDA?

A-Sorb (K882115) received a 510(k) decision of Substantially Equivalent on October 3, 1988, 137 days after the submission was received.

What is the product code of K882115?

The FDA product code is NAB – Gauze / Sponge,Nonresorbable For External Use, a Class I (low risk) device regulated under 21 CFR 878.4014.