Panels › General, Plastic Surgery › Product code GAR · Class 2
Suture, Nonabsorbable, Synthetic, Polyamide
Regulation 878.5020
1510(k)s in 12 months (57 all time)
1recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in GAR
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien LP | 0 | 6 |
| Aesculap, Inc. | 3 | 1 |
| S. Jackson, Inc. | 4 | 0 |
| Look, Inc. | 3 | 0 |
| Riverpoint Medical | 1 | 2 |
| Surgical Specialties, Inc. | 1 | 2 |
| Sutures , Ltd. | 3 | 0 |
| Tas Medical, Inc. | 2 | 1 |
| United States Surgical, A Division of Tyco Healthc | 3 | 0 |
| Artimplant AB | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Covidien, LP Dermalon
88861757-31 DERMALON* 4-0 BLU 75CM C13
88861757-31
88861799-31 DERMALON* 4-0 BLU 75CM C14
88861799-31 Open, Classified |
GAR | K981582 |
| Mar 6, 2025 | TAS Medical Inc TISSUE APPROXIMATION SYSTEM (TAS),
Models T-4000, T-5000, T-LAP Open, Classified |
GAR | K220980 |
| Jan 29, 2024 | Covidien LP Surgilon Braided Nylon sutures:
88861919-31 SURGILON* 4-0 BLK 7X75CMPCT
88861919-41 SURGILON* 3-0 BLK 7X75CMPCT
88861919-51 SURGILON* 2-0 BLK 7X75CMPCT
88861919-71 SURGILON* 1 BLK 7X75CM PCT Open, Classified |
GAR | K981582 |
| Feb 25, 2023 | Covidien, LP Surgilon Braided Nylon suture
Product Description:
88861883-51 SURGILON* 2-0 BLK 75CM C16
88861915-71 SURGILON* 1 BLK 75CM GS11
88861919-31 SURGILON* 4-0 BLK 7X75CMPCT
88861919-41 SURGILON* 3-0 BLK 7X Open, Classified |
GAR | K981582 |
| Feb 25, 2023 | Covidien, LP Monosof Monofilament Nylon sutures:
Product Description
CN-724 MONOSOF* 1 BLK 100CM GS25 X36
CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36
CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90
C Open, Classified |
GAR | K900531 |
| Feb 25, 2023 | Covidien, LP Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded)
(1) S661GX 5-0 NYLON 18 DS18
(2)S683GX 4-0 SILK 18 DS18
(3) S683GX 4-0 SILK 18 DS18 Open, Classified |
GAR | K900531 |
| Feb 25, 2023 | Covidien, LP Dermalon Monofilament Nylon Suture:
(1) 88861741-11 DERMALON* 6-0 BLU 45CM C1
(2) 88861747-11 DERMALON* 6-0 BLU 45CM C12
(3) 88861749-24 DERMALON* 5-0 BLU 45CM P13
(4) 88861756-11 DERMALON* 6-0 BLU 4 Open, Classified |
GAR | K981582 |
| Aug 5, 2016 | Riverpoint Medical, LLC Polypropylene Surgical Sutures, brand Webglo, for vet use. Product is sterile. Part number: GP8665
Product Usage:
For use in general soft tissue approximation and/or ligation, including use in cardio Terminated |
GAR | K100006 |
| Aug 5, 2016 | Riverpoint Medical, LLC Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers:
663BK
663BL
664BL
928BK
Product Usage:
For use in general soft t Terminated |
GAR | K100006 |
| Jul 9, 2014 | Aesculap, Inc. Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding Terminated |
GAR | K990090 |
| May 7, 2014 | Teleflex Medical Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel.
Indicated for use in soft tissue approximation. Terminated |
GAR | K930738 |
| Sep 9, 2011 | C P Medical Inc. Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes.
The products are labeled in parts.
These sutures are intended for u Terminated |
GAR | K001173 |
| Oct 2, 2008 | Surgical Specialties Corp 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures. Terminated |
GAR | K930825 |
| Oct 21, 2005 | Surgical Specialties Corp Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units. Terminated |
GAR | None listed |
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