Suture, Absorbable, Natural
FDA product code GAL · Class II (moderate risk) · 21 CFR 878.4830 · General, Plastic Surgery
30510(k) clearances
0PMA approvals
5recalls
Implantimplanted device
Manufacturers
- United States Surgical, A Division of Tyco Healthc 4
- Look, Inc. 3
- Surgimetrics International, Ltd. 2
- Sutures , Ltd. 2
- Covidien LLC 1
- Ethicon Endo-Surgery, Inc. 1
- Suturtek Incorporated 1
- Serral, S.A. DE C.V. 1
- Gramsmed, LLC 1
- Qrc Consulting 1
- Cp Medical 1
- Arc Medical Supplies (Beijing) Co, Ltd. 1
- Hysterx, Inc. 1
- Trading Consultants and Distributors Intl., Inc. 1
- Myco Medical Supplies, Inc. 1
- Aesculap, Inc. 1
- R. K. Medical L. L. C. 1
- Deknatel, Inc. 1
- Lukens Medical Corp. 1
- Davis & Geck, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142656 | Surgical Gut SutureGAL · Special | Covidien | 01/29/2015SE |
| K072930 | Demetech Absorbable Surgical Suture Plain & Chromic GutGAL · Traditional | Demetech Corp. | 04/30/2008SE |
| K042287 | Uniplain & UnichromGAL · Traditional | United Medical Industries Co. , Ltd. | 09/07/2005SE |
| K042897 | Autobahn Tissue Closure Device and Disposable CartridgeGAL · Traditional | Ethicon Endo-Surgery, Inc. | 11/19/2004SE |
| K030227 | Suturtek Fastclose Suturing DeviceGAL · Traditional | Suturtek Incorporated | 03/17/2003SE |
| K020597 | SerralgutGAL · Traditional | Serral, S.A. DE C.V. | 08/14/2002SE |
| K021043 | Grams Absorbable Surgical Gut Suture Plain & ChromicGAL · Traditional | Gramsmed, LLC | 06/21/2002SE |
| K011105 | Suturtek Fastclose Fascia Closure DeviceGAL · Traditional | Qrc Consulting | 05/30/2001SE |
| K001299 | Plain and Chromic Gut Absorbable Surgical Sutures UspGAL · Traditional | Cp Medical | 06/23/2000SN |
| K000542 | Plain and Chronic Gut Absorbable Surgical Sutures, UspGAL · Traditional | Arc Medical Supplies (Beijing) Co, Ltd. | 04/28/2000SE |
| K993695 | Liga-Loop Suture ApplicatorGAL · Traditional | Hysterx, Inc. | 04/13/2000SE |
| K994002 | Plain/Chromic CatgutGAL · Traditional | Trading Consultants and Distributors Intl., Inc. | 02/04/2000SE |
| K982646 | Ailee Sutures and Ailee NeedlesGAL · Traditional | Myco Medical Supplies, Inc. | 06/02/1999SE |
| K991223 | Absorbable Surgical Gut Suture, Plain and Chronic and Softcat Absorbable Surgical Gut…GAL · Traditional | Aesculap, Inc. | 04/30/1999SE |
| K961931 | Plain Gut & Chronic Gut Absorbable Surgical Sutures UspGAL · Traditional | R. K. Medical L. L. C. | 07/29/1996SE |
| K943218 | Chromic CatgutGAL · Traditional | Sutures , Ltd. | 12/05/1994SN |
| K943217 | Plain CatgutGAL · Traditional | Sutures , Ltd. | 12/05/1994SN |
| K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcGAL · Traditional | Deknatel, Inc. | 07/26/1994SE |
| K930416 | Surgical Suture Package InsertsGAL · Traditional | United States Surgical, A Division of Tyco Healthc | 04/28/1994SN |
| K931919 | Catgut Suture ChromicGAL · Traditional | Surgimetrics International, Ltd. | 03/03/1994SE |
| K931918 | Catgut Suture PlainGAL · Traditional | Surgimetrics International, Ltd. | 03/03/1994SE |
| K926586 | Revised Labeling for Chromic and Plain Gut SuturesGAL · Traditional | Look, Inc. | 12/22/1993SE |
| K930944 | Lukens Surgical Gut SutureGAL · Traditional | Lukens Medical Corp. | 12/17/1993SE |
| K930589 | Plain, Mild Chromic and Chromic Surgical Gut SuturGAL · Traditional | Davis & Geck, Inc. | 12/17/1993SE |
| K911354 | Sterile Plain Gut/Chromic Gut Absorb Surg SuturesGAL · Traditional | Internacional Farmaceutica, S.A. DE C.V. | 10/25/1991SE |
| K904588 | Auto Suture(R) Modified Endoscopic Ligating LoopGAL · Traditional | United States Surgical, A Division of Tyco Healthc | 12/24/1990SE |
| K903624 | Plain and Chromic Gut SutureGAL · Traditional | Look, Inc. | 09/18/1990SN |
| K902731 | Endoscopic Hemostatic Ligating LoopGAL · Traditional | United States Surgical, A Division of Tyco Healthc | 09/07/1990SN |
| K896554 | Gut SuturesGAL · Traditional | Look, Inc. | 05/31/1990SN |
| K885018 | Absorbable Surgical Gut Suture*GAL · Traditional | United States Surgical, A Division of Tyco Healthc | 08/22/1989SN |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1390-2023 Class II | Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD…Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may… | Covidien, LP | 03/01/2023Open, Classified |
| Z-1389-2023 Class II | Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC…Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may… | Covidien, LP | 03/01/2023Open, Classified |
| Z-1388-2023 Class II | Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR…Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may… | Covidien, LP | 03/01/2023Open, Classified |
| Z-1027-2019 Class II | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product…Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit… | CP Medical Inc | 02/04/2019Open, Classified |
| Z-1839-2015 Class II | Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical…Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and… | Ethicon, Inc. | 05/08/2015Terminated |