Mar-Med Liver Strap

FDA 510(k) K924223 · Mar-Med Co.

Substantially Equivalent

510(k) numberK924223

Submission

Device name
Mar-Med Liver Strap
Applicant
Mar-Med Co.
Grand Rapids, MI, US
Received
August 21, 1992
Decision date
March 18, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GDJ – Clamp, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GDJ

510(k)DeviceApplicantDecision
K153358Standard ClampGDJ · Traditional Standard Bariatrics05/02/2016SE
K930315Thoracic Clamps: Sarot, Kantowitz and LawrenceGDJ · Traditional Thomasville Medical Assoc.02/04/1994SE
K922659General Surgery Clamp and Needle HolderGDJ · Traditional Miltex Instrument Co.07/21/1992SE
K914913Grice Foot Pedal Control/Reddick Irri/Aspir SystGDJ · Traditional Ideal Medical, Inc.12/31/1991SE
K900956GS-7100 Cholangiogram Clamp, 5MMGDJ · Traditional Solos Endoscopy, Inc.04/18/1990SE
K901107Modified Auto Suture Purstring Disp. AutomaticGDJ · Traditional United States Surgical, A Division of Tyco Healthc04/09/1990SE
K895726Vessel OccluderGDJ · Traditional Applied Medical Technologies10/24/1989SE
K895591Silicone Instrument ShodsGDJ · Traditional Key Surgical, Inc.10/20/1989SE
K882169Surgical Duct Clamp (Vine)GDJ · Traditional Henley Intl.06/17/1988SE
K881741Stuart Lee ClipGDJ · Traditional Stuart-Lee, Inc.06/03/1988SE

Questions and answers

When was Mar-Med Liver Strap cleared by the FDA?

Mar-Med Liver Strap (K924223) received a 510(k) decision of Substantially Equivalent on March 18, 1993, 209 days after the submission was received.

What is the product code of K924223?

The FDA product code is GDJ – Clamp, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.