Product code GAL
- Device name
- Suture, Absorbable, Natural
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4830
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| N84381S007 | CHROMIC GUT SUTURE | Deknatel, Inc. | 1989-01-31 |
| N84380S007 | PLAIN GUT SUTURES | Deknatel, Inc. | 1989-01-31 |
| N8536S024 | CATGUT SUTURE | ETHICON, Inc. | 1988-12-22 |
| N84381S008 | CHROMIC GUT SUTURE | Deknatel, Inc. | 1988-04-28 |
| N84380S008 | PLAIN GUT SUTURES | Deknatel, Inc. | 1988-04-28 |
| N84381S006 | CHROMIC GUT SUTURE | Deknatel, Inc. | 1988-02-22 |
| N84380S006 | PLAIN GUT SUTURES | Deknatel, Inc. | 1988-02-22 |
| N10389S026 | ABSORBABLE SURGICAL SUTURE, USP | ETHICON, Inc. | 1987-10-05 |
| N14226S008 | ABSORBABLE SURGICAL SUTURE, USP | ETHICON, Inc. | 1987-08-28 |
| N10389S025 | ABSORBABLE SURGICAL SUTURE, USP | ETHICON, Inc. | 1987-08-28 |
| N8536S023 | CATGUT SUTURE | ETHICON, Inc. | 1987-06-18 |
| N15405S007 | COLLAGEN SUTURE (PLAIN CHROMIC) ABSORBABLE | ETHICON, Inc. | 1987-06-18 |
| N14226S007 | ABSORBABLE SURGICAL SUTURE, USP | ETHICON, Inc. | 1987-06-18 |
| N10389S024 | ABSORBABLE SURGICAL SUTURE, USP | ETHICON, Inc. | 1987-06-18 |
| N83433S020 | CHROMIC GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. | 1987-02-20 |
| N83038S020 | PLAIN GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. | 1987-02-20 |
| N8536S022 | CATGUT SUTURE | ETHICON, Inc. | 1986-06-20 |
| N15405S006 | COLLAGEN SUTURE (PLAIN!CHROMIC) ABSORBABLE | ETHICON, Inc. | 1986-06-20 |
| N14226S006 | ABSORBABLE SURGICAL SUTURE, USP | ETHICON, Inc. | 1986-06-20 |
| N10389S023 | ABSORBABLE SURGICAL SUTURE, USP | ETHICON, Inc. | 1986-06-20 |
| N83433S019 | CHROMIC GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. | 1985-09-17 |
| N83038S019 | PLAIN GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. | 1985-09-17 |
| N84381S005 | CHROMIC GUT SUTURE | Deknatel, Inc. | 1985-02-27 |
| N84380S005 | PLAIN GUT SUTURES | Deknatel, Inc. | 1985-02-27 |
| N84381S004 | CHROMIC GUT SUTURE | Deknatel, Inc. | 1984-07-12 |
| N84380S004 | PLAIN GUT SUTURES | Deknatel, Inc. | 1984-07-12 |
| N83038S018 | PLAIN GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. | 1984-04-27 |
| N8536S021 | CATGUT SUTURE | ETHICON, Inc. | 1984-04-04 |
| N10389S022 | ABSORBABLE SURGICAL SUTURE, USP | ETHICON, Inc. | 1984-04-04 |
| N8536S020 | CATGUT SUTURE | ETHICON, Inc. | 1983-11-17 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142656 | Surgical Gut Suture | Covidien | 2015-01-29 |
| K072930 | DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT | Demetech Corp. | 2008-04-30 |
| K042287 | UNIPLAIN & UNICHROM | United Medical Industries Co. , Ltd. | 2005-09-07 |
| K042897 | AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE | Ethicon Endo-Surgery, Inc. | 2004-11-19 |
| K030227 | SUTURTEK FASTCLOSE SUTURING DEVICE | Suturtek Incorporated | 2003-03-17 |
| K020597 | SERRALGUT | Serral, S.A. DE C.V. | 2002-08-14 |
| K021043 | GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC | Gramsmed, LLC | 2002-06-21 |
| K011105 | SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE | Qrc Consulting | 2001-05-30 |
| K001299 | PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP | Cp Medical | 2000-06-23 |
| K000542 | PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP | Arc Medical Supplies (Beijing) Co, Ltd. | 2000-04-28 |
| K993695 | LIGA-LOOP SUTURE APPLICATOR | Hysterx, Inc. | 2000-04-13 |
| K994002 | PLAIN/CHROMIC CATGUT | Trading Consultants and Distributors Intl., Inc. | 2000-02-04 |
| K982646 | AILEE SUTURES AND AILEE NEEDLES | Myco Medical Supplies, Inc. | 1999-06-02 |
| K991223 | ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC | Aesculap, Inc. | 1999-04-30 |
| K961931 | PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP | R. K. Medical L. L. C. | 1996-07-29 |
| K943217 | PLAIN CATGUT | Sutures , Ltd. | 1994-12-05 |
| K943218 | CHROMIC CATGUT | Sutures , Ltd. | 1994-12-05 |
| K930738 | SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETC | Deknatel, Inc. | 1994-07-26 |
| K930416 | SURGICAL SUTURE PACKAGE INSERTS | United States Surgical, A Division of Tyco Healthc | 1994-04-28 |
| K931918 | CATGUT SUTURE PLAIN | Surgimetrics International, Ltd. | 1994-03-03 |
| K931919 | CATGUT SUTURE CHROMIC | Surgimetrics International, Ltd. | 1994-03-03 |
| K926586 | REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES | Look, Inc. | 1993-12-22 |
| K930589 | PLAIN, MILD CHROMIC AND CHROMIC SURGICAL GUT SUTUR | Davis & Geck, Inc. | 1993-12-17 |
| K930944 | LUKENS SURGICAL GUT SUTURE | Lukens Medical Corp. | 1993-12-17 |
| K911354 | STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES | Internacional Farmaceutica, S.A. DE C.V. | 1991-10-25 |
| K904588 | AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP | United States Surgical, A Division of Tyco Healthc | 1990-12-24 |
| K903624 | PLAIN AND CHROMIC GUT SUTURE | Look, Inc. | 1990-09-18 |
| K902731 | ENDOSCOPIC HEMOSTATIC LIGATING LOOP | United States Surgical, A Division of Tyco Healthc | 1990-09-07 |
| K896554 | GUT SUTURES | Look, Inc. | 1990-05-31 |
| K885018 | ABSORBABLE SURGICAL GUT SUTURE* | United States Surgical, A Division of Tyco Healthc | 1989-08-22 |
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|---|---|---|---|
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| 10652927129097 | DemeGUT | Demetech Corporation | 2019-07-22 |
| 10652927121824 | DemeGUT | Demetech Corporation | 2019-07-22 |
| 10652927111276 | DemeGUT | Demetech Corporation | 2019-07-22 |
| 10652927148999 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927148982 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927148685 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927148678 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927148661 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927147879 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927129295 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927119128 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927112082 | DemeGUT | Demetech Corporation | 2019-06-14 |
| 10652927110910 | DemeGUT | Demetech Corporation | 2019-06-13 |
| 10652927110842 | DemeGUT | Demetech Corporation | 2017-03-21 |
| 10652927110828 | DemeGUT | Demetech Corporation | 2017-03-21 |
| 10652927110811 | DemeGUT | Demetech Corporation | 2017-03-21 |
| 10652927100089 | DemeGUT | Demetech Corporation | 2017-03-21 |
| 10652927100027 | DemeGUT | Demetech Corporation | 2017-03-21 |
| 10652927134268 | DemeGUT | Demetech Corporation | 2017-03-21 |
| M220P4206353 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| M220P54206363 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
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