GAL · Suture, Absorbable, Natural
General, Plastic Surgery · 21 CFR 878.4830 · Class 2
Overview
| Product Code | GAL |
|---|---|
| Device Name | Suture, Absorbable, Natural |
| Regulation | 21 CFR 878.4830 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142656 | Surgical Gut Suture | Covidien | Jan 29, 2015 | SESE |
| K072930 | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT | Demetech Corp. | Apr 30, 2008 | SESE |
| K042287 | UNIPLAIN & UNICHROM | United Medical Industries Co. , Ltd. | Sep 7, 2005 | SESE |
| K042897 | AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE | Ethicon Endo-Surgery, Inc. | Nov 19, 2004 | SESE |
| K030227 | SUTURTEK FASTCLOSE SUTURING DEVICE | Suturtek Incorporated | Mar 17, 2003 | SESE |
| K020597 | SERRALGUT | Serral, S.A. DE C.V. | Aug 14, 2002 | SESE |
| K021043 | GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC | Gramsmed, LLC | Jun 21, 2002 | SESE |
| K011105 | SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE | Qrc Consulting | May 30, 2001 | SESE |
| K001299 | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP | Cp Medical | Jun 23, 2000 | SN |
| K000542 | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | Apr 28, 2000 | SESE |
| K993695 | LIGA-LOOP SUTURE APPLICATOR | Hysterx, Inc. | Apr 13, 2000 | SESE |
| K994002 | PLAIN/CHROMIC CATGUT | Trading Consultants and Distributors Intl., Inc. | Feb 4, 2000 | SESE |
| K982646 | AILEE SUTURES AND AILEE NEEDLES | Myco Medical Supplies, Inc. | Jun 2, 1999 | SESE |
| K991223 | ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC | Aesculap, Inc. | Apr 30, 1999 | SESE |
| K961931 | PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | Jul 29, 1996 | SESE |
| K943218 | CHROMIC CATGUT | Sutures , Ltd. | Dec 5, 1994 | SN |
| K943217 | PLAIN CATGUT | Sutures , Ltd. | Dec 5, 1994 | SN |
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC | Deknatel, Inc. | Jul 26, 1994 | SESE |
| K930416 | SURGICAL SUTURE PACKAGE INSERTS | United States Surgical, A Division of Tyco Healthc | Apr 28, 1994 | SN |
| K931919 | CATGUT SUTURE CHROMIC | Surgimetrics International, Ltd. | Mar 3, 1994 | SESE |
Top Applicants
- United States Surgical, A Division of Tyco Healthc — 4 clearances
- Look, Inc. — 3 clearances
- Surgimetrics International, Ltd. — 2 clearances
- Sutures , Ltd. — 2 clearances
- Aesculap, Inc. — 1 clearance
