Panels › General, Plastic Surgery › Product code GAW · Class 2
Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation 878.5010
1510(k)s in 12 months (85 all time)
2recalls in 12 months (28 all time)
26recalls that name a 510(k)
Top companies in GAW
| Company | 510(k)s | Recalls |
|---|---|---|
| ETHICON, Inc. | 4 | 22 |
| Axya Medical, Inc. | 5 | 0 |
| Surgical Specialties Corp | 5 | 0 |
| Covidien, LP | 0 | 4 |
| Sutura, Inc. | 4 | 0 |
| Aesculap, Inc. | 3 | 0 |
| Nobles Medical Technologies Ii, Inc. | 3 | 0 |
| United States Surgical, A Division of Tyco Healthc | 3 | 0 |
| Abbott Vascular, Inc. | 2 | 0 |
| Angiotech | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Covidien, LP Surgipro II
S8698GX SURGIPRO II BL 5/0 18 P-13
S8698GX Open, Classified |
GAW | K050947 |
| Aug 7, 2026 | Covidien, LP Surgipro
SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36
SP-623 Open, Classified |
GAW | None listed |
| Feb 4, 2025 | Ethicon, LLC ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H.
Not sold in US Open, Classified |
GAW | None listed |
| Feb 4, 2025 | Ethicon, LLC PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic an Open, Classified |
GAW | K946173 |
| Feb 4, 2025 | Ethicon, LLC PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophtha Open, Classified |
GAW | K133356 |
| Feb 25, 2023 | Covidien, LP Surgipro II Monofilament Polypropylene Sutures
Product Description Model Number
VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X
VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X
VP-541X SURGIPRO*II 4-0 BLU 1 Open, Classified |
GAW | K050947 |
| Feb 25, 2023 | Covidien, LP Surgipro Monofilament Polypropylene Sutures
Product Description
CP-535 SURGIPRO* 1 BLU 100CM GS24 X36
CP-824 SURGIPRO* 1 BLU 150CM GS26 X24
CP-825 SURGIPRO* 2 BLU 150CM GS26 X24
VP-543 SURGIPRO* 2-0 B Open, Classified |
GAW | K954808 |
| May 7, 2018 | Ethicon, Inc. PRONOVA SUTURE BLUE 122CM M1.5, D10189 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981 Terminated |
GAW | K133356 |
| May 7, 2018 | Ethicon, Inc. PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031 Terminated |
GAW | K133356 |
| May 20, 2016 | SSC- Surgical Specialties Corporation Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N Terminated |
GAW | K904906 |
| May 24, 2007 | C P Medical Product is an EO Sterile, Blue Polypropylene monofilament synthetic nonabsorbable surgical suture with needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle. Product is wrapped in a five-fold card with Terminated |
GAW | K001185 |
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