Ethicon
Chromic Gut, Sterile, Absorbable Surgical Suture with Control Release Removable Needles
1manufacturer
231catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Ethicon, Inc., United States |
|---|---|
| FDA product code | GAL |
| Device type | Suture, Absorbable, Natural |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4830 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K946173 |
| Record published | 2015-09-01 |
| Record revised | 2021-12-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 36, box of 12, box of 24 |
| Distribution end date | 2022-09-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S105H | In distribution | |
| 865H | In distribution | |
| 904H | In distribution | |
| U207H | In distribution | |
| G128H | In distribution | |
| U255H | In distribution | |
| 52T | In distribution | |
| 975H | In distribution | |
| 805H | In distribution | |
| S104H | In distribution | |
| SG15T | In distribution | |
| 1642G | In distribution | |
| 1636G | In distribution | |
| D9989 | In distribution | |
| 1654G | In distribution | |
| 44T | In distribution | |
| SG2T | In distribution | |
| S103H | In distribution | |
| L101G | In distribution | |
| 1735G | In distribution | |
| 883H | In distribution | |
| 1630H | In distribution | |
| 790G | In distribution | |
| G182H | In distribution | |
| G122H | In distribution | |
| 932H | In distribution | |
| S112H | In distribution | |
| 898H | In distribution | |
| L112G | In distribution | |
| 862H | In distribution | |
| 4923H | In distribution | |
| 1915G | In distribution | |
| SG13T | In distribution | |
| 770G | In distribution | |
| 849G | In distribution | |
| L102G | In distribution | |
| 1635G | In distribution | |
| 794G | In distribution | |
| S102H | In distribution | |
| CP53G | In distribution | |
| 774G | In distribution | |
| 1745G | In distribution | |
| G127H | In distribution | |
| 798G | In distribution | |
| S116H | In distribution | |
| 838H | In distribution | |
| 884H | In distribution | |
| S111H | In distribution | |
| 864H | In distribution | |
| 3803T | In distribution | |
| L114G | In distribution | |
| H821H | In distribution | |
| N879H | In distribution | |
| 983H | In distribution | |
| 945H | In distribution | |
| 814H | In distribution | |
| G322H | In distribution | |
| 1772G | In distribution | |
| 638G | In distribution | |
| 4915H | In distribution | |
| N877H | In distribution | |
| 3812T | In distribution | |
| 912H | In distribution | |
| 2644G | In distribution | |
| 742G | In distribution | |
| 4924H | In distribution | |
| 687G | In distribution | |
| 915H | In distribution | |
| 905H | In distribution | |
| G123H | In distribution | |
| 3811T | In distribution | |
| 1659G | In distribution | |
| 1637G | In distribution | |
| 925H | In distribution | |
| G181H | In distribution | |
| 795G | In distribution | |
| G172H | In distribution | |
| CC38G | In distribution | |
| 1627H | In distribution | |
| 811H | In distribution | |
| G124H | In distribution | |
| 803H | In distribution | |
| 635H | In distribution | |
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| 1798G | In distribution | |
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| 796G | In distribution | |
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| L111G | In distribution | |
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| 1653G | In distribution | |
| S117H | In distribution | |
| N863H | In distribution | |
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| U213H | In distribution | |
| 844H | In distribution | |
| M760G | In distribution | |
| 1641G | In distribution | |
| 837H | In distribution | |
| 833H | In distribution | |
| 817H | In distribution | |
| 658G | In distribution | |
| 637H | In distribution | |
| C101H | In distribution | |
| 872H | In distribution | |
| GL31G | In distribution | |
| 636H | In distribution | |
| 1775G | In distribution | |
| CC41G | In distribution | |
| H822H | In distribution | |
| 2643G | In distribution | |
| CC04G | In distribution | |
| 598H | In distribution | |
| D10036 | In distribution | |
| SG14T | In distribution | |
| 1652G | In distribution | |
| 775G | In distribution | |
| 903H | In distribution | |
| 723G | In distribution | |
| 744G | In distribution | |
| 813H | In distribution | |
| 913H | In distribution | |
| S114H | In distribution | |
| 982H | In distribution | |
| 634G | In distribution | |
| 846H | In distribution | |
| 1731G | In distribution | |
| 1632G | In distribution | |
| L113G | In distribution | |
| 1640H | In distribution | |
| 612G | In distribution | |
| CC40G | In distribution | |
| 773G | In distribution | |
| G152H | In distribution | |
| 843H | In distribution | |
| 5589T | In distribution | |
| 991H | In distribution | |
| S113H | In distribution | |
| K895H | In distribution | |
| N878H | In distribution | |
| N862H | In distribution | |
| 816H | In distribution | |
| U246H | In distribution | |
| 801H | In distribution | |
| 887H | In distribution | |
| L103G | In distribution | |
| 812H | In distribution | |
| G173H | In distribution | |
| 842H | In distribution | |
| 53T | In distribution | |
| G321H | In distribution | |
| 929H | In distribution | |
| G126H | In distribution | |
| 1626G | In distribution | |
| 832H | In distribution | |
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| 800H | In distribution | |
| 943H | In distribution | |
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| 944H | In distribution | |
| 1638H | In distribution | |
| 977H | In distribution | |
| 863H | In distribution | |
| 914H | In distribution | |
| S115H | In distribution | |
| 724G | In distribution | |
| CC03G | In distribution | |
| 942H | In distribution | |
| 1828H | In distribution | |
| 1643G | In distribution | |
| 1644G | In distribution | |
| 793G | In distribution | |
| 1816G | In distribution | |
| 885H | In distribution | |
| H810H | In distribution | |
| 752G | In distribution | |
| 47T | In distribution | |
| L115G | In distribution | |
| U202H | In distribution | |
| 4994H | In distribution | |
| 1766G | In distribution | |
| 654H | In distribution | |
| 792G | In distribution | |
| H823H | In distribution | |
| 852H | In distribution | |
| 665H | In distribution | |
| 839H | In distribution | |
| N864H | In distribution | |
| G121H | In distribution | |
| 886H | In distribution | |
| L104G | In distribution | |
| 888H | In distribution | |
| 4995H | In distribution | |
| 882H | In distribution | |
| 772G | In distribution | |
| 924H | In distribution | |
| D8005 | In distribution | |
| U204H | In distribution | |
| GL30G | In distribution | |
| 3813G | In distribution | |
| U245H | In distribution | |
| CC02G | In distribution | |
| 810H | In distribution | |
| 802H | In distribution | |
| G133H | In distribution | |
| 873H | In distribution | |
| 1658G | In distribution | |
| CC01G | In distribution | |
| 1824H | In distribution | |
| 5503T | In distribution | |
| 853H | In distribution | |
| 1744G | In distribution | |
| U203H | In distribution | |
| 751G | In distribution | |
| 686G | In distribution | |
| 894H | In distribution | |
| 1797G | In distribution | |
| 4925H | In distribution | |
| H820G | In distribution | |
| 1633G | In distribution | |
| 48G | In distribution | |
| 1791G | In distribution | |
| 892H | In distribution | |
| 923H | In distribution | |
| 922H | In distribution | |
| 1916G | Withdrawn | |
| 921H | Withdrawn | |
| 3802T | Withdrawn | |
| U247H | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeGUT | Demetech Corp. | 1,421 |
| Softcat | B Braun Surgical SA | 338 |
| Catgut | B Braun Surgical SA | 147 |
| Chromic Gut | Covidien LP | 142 |
| Plain Gut | Covidien LP | 68 |
| Reli® | Myco Medical Supplies, Inc. | 63 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 60 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 52 |
| Sharpoint | Surgical Specialties México, S. de R.L. de C.V. | 46 |
| Suture, Absorbable, Natural | C P Medical Inc. | 44 |
| Chromic Gut | Riverpoint Medical LLC | 33 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 30 |
Showing 12 of 237. All products under Suture, Absorbable, Natural
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon, Inc. | 510(k) number | 2015-05-08 | Class II | Labeling mix-ups | Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete. | 1,922 units | 2017-06-06 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N14226 | 1987-08-28 | ABSORBABLE SURGICAL SUTURE, USP | Ethicon, Inc. |
| N10389 | 1987-06-18 | ABSORBABLE SURGICAL SUTURE, USP | Ethicon, Inc. |
| N84380 | 1985-02-27 | PLAIN GUT SUTURES | Deknatel, Inc. |
| N83038 | 1984-04-27 | PLAIN GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. |
| N83433 | 1983-08-18 | CHROMIC GUT STERILE ABSORBABLE SUTURES | Davis & Geck, Inc. |
| N84381 | 1981-08-11 | GUT | Deknatel, Inc. |
| N8536 | 1981-01-06 | CATGUT SUTURE | Ethicon, Inc. |
| N15405 | 1981-01-06 | COLLAGEN SUTURE (PLAIN!CHROMIC) ABSORBABLE | Ethicon, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.