Cleared Traditional

GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC

K021043 · Gramsmed, LLC · General & Plastic Surgery
Jun 2002
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K021043 is an FDA 510(k) clearance for the GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC, a Suture, Absorbable, Natural (Class II — Special Controls, product code GAL), submitted by Gramsmed, LLC (Grafton, US). The FDA issued a Cleared decision on June 21, 2002, 81 days after receiving the submission on April 1, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4830.

Submission Details

510(k) Number K021043 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2002
Decision Date June 21, 2002
Days to Decision 81 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAL — Suture, Absorbable, Natural
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4830

Similar Devices — GAL Suture, Absorbable, Natural

All 29
Surgical Gut Suture
K142656 · Covidien · Jan 2015
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
K072930 · Demetech Corp. · Apr 2008
UNIPLAIN & UNICHROM
K042287 · United Medical Industries Co. , Ltd. · Sep 2005
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
K042897 · Ethicon Endo-Surgery, Inc. · Nov 2004
SUTURTEK FASTCLOSE SUTURING DEVICE
K030227 · Suturtek Incorporated · Mar 2003
SERRALGUT
K020597 · Serral, S.A. DE C.V. · Aug 2002