FDA Product Code
FDA Product Code GAL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4830
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K142656 | Surgical Gut Suture | Covidien | 2015-01-29 | Special | PDF ↗ |
| K072930 | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT | Demetech Corp. | 2008-04-30 | Traditional | PDF ↗ |
| K042287 | UNIPLAIN & UNICHROM | United Medical Industries Co. , Ltd. | 2005-09-07 | Traditional | PDF ↗ |
| K042897 | AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE | Ethicon Endo-Surgery, Inc. | 2004-11-19 | Traditional | PDF ↗ |
| K030227 | SUTURTEK FASTCLOSE SUTURING DEVICE | Suturtek Incorporated | 2003-03-17 | Traditional | PDF ↗ |
| K020597 | SERRALGUT | Serral, S.A. DE C.V. | 2002-08-14 | Traditional | PDF ↗ |
| K021043 | GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC | Gramsmed, LLC | 2002-06-21 | Traditional | PDF ↗ |
| K011105 | SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE | Qrc Consulting | 2001-05-30 | Traditional | PDF ↗ |
| K001299 | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP | Cp Medical | 2000-06-23 | Traditional | PDF ↗ |
| K000542 | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 | Traditional | PDF ↗ |
| K993695 | LIGA-LOOP SUTURE APPLICATOR | Hysterx, Inc. | 2000-04-13 | Traditional | PDF ↗ |
| K994002 | PLAIN/CHROMIC CATGUT | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K982646 | AILEE SUTURES AND AILEE NEEDLES | Myco Medical Supplies, Inc. | 1999-06-02 | Traditional | PDF ↗ |
| K991223 | ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC | Aesculap, Inc. | 1999-04-30 | Traditional | PDF ↗ |
| K961931 | PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-07-29 | Traditional | PDF ↗ |
| K943217 | PLAIN CATGUT | Sutures , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K943218 | CHROMIC CATGUT | Sutures , Ltd. | 1994-12-05 | Traditional | PDF ↗ |
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC | Deknatel, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K930416 | SURGICAL SUTURE PACKAGE INSERTS | United States Surgical, A Division of Tyco Healthc | 1994-04-28 | Traditional | PDF ↗ |
| K931918 | CATGUT SUTURE PLAIN | Surgimetrics International, Ltd. | 1994-03-03 | Traditional | PDF ↗ |
| K931919 | CATGUT SUTURE CHROMIC | Surgimetrics International, Ltd. | 1994-03-03 | Traditional | PDF ↗ |
| K926586 | REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES | Look, Inc. | 1993-12-22 | Traditional | PDF ↗ |
| K930944 | LUKENS SURGICAL GUT SUTURE | Lukens Medical Corp. | 1993-12-17 | Traditional | PDF ↗ |
| K930589 | PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR | Davis & Geck, Inc. | 1993-12-17 | Traditional | PDF ↗ |
| K911354 | STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 1991-10-25 | Traditional | PDF ↗ |
| K904588 | AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP | United States Surgical, A Division of Tyco Healthc | 1990-12-24 | Traditional | PDF ↗ |
| K903624 | PLAIN AND CHROMIC GUT SUTURE | Look, Inc. | 1990-09-18 | Traditional | PDF ↗ |
| K902731 | ENDOSCOPIC HEMOSTATIC LIGATING LOOP | United States Surgical, A Division of Tyco Healthc | 1990-09-07 | Traditional | PDF ↗ |
| K896554 | GUT SUTURES | Look, Inc. | 1990-05-31 | Traditional | PDF ↗ |
| K885018 | ABSORBABLE SURGICAL GUT SUTURE* | United States Surgical, A Division of Tyco Healthc | 1989-08-22 | Traditional | PDF ↗ |
Product code GAL · Class II · General, Plastic Surgery. Data: openFDA.