Panels › General, Plastic Surgery › Product code GAM · Class 2
Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation 878.4493
6510(k)s in 12 months (150 all time)
2recalls in 12 months (130 all time)
124recalls that name a 510(k)
Top companies in GAM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 2/0 Undyed 30" V-20 Taper,
Product Number: CV417G, UDI: 20884521149370 - Product Usage: indicated for use in soft tissue approximation of the Terminated |
GAM | K120556 |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of th Terminated |
GAM | K120556 |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation Terminated |
GAM | K120556 |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of th Terminated |
GAM | K120556 |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of th Terminated |
GAM | K120556 |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of t Terminated |
GAM | K120556 |
| Feb 19, 2020 | Covidien LLC Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular o Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neu Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neu Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascu Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular o Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovasc Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular o Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular o Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or n Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or Terminated |
GAM | K000037 |
| Feb 19, 2020 | Covidien LLC Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovas Terminated |
GAM | K000037 |
| Feb 4, 2020 | Ethicon, Inc. Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture. Terminated |
GAM | K022269 |
| Oct 18, 2019 | CP Medical Inc Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970 Open, Classified |
GAM | K002190 |
| Mar 12, 2019 | Ethicon, Inc. VICRYL Sutures
VICRYL SUTURE 18"(45CM) 0 VIO
VICRYL SUTURE 18"(45CM) 4-0 UND
VICRYL SUTURE 18"(45CM) 2-0 VIO
VICRYL SUTURE 18"(45CM) 0 VIO
VICRYL SUTURE 18"(45CM) 2-0 VIO
VICRYL CT VIO 8X18IN 0 S/A CT Terminated |
GAM | K022715 |
| Jun 15, 2018 | Covidien LLC Polysorb Braided Absorbable Suture 1 36" 90 cm
Undyed GS-21, Product Number CL-955 Terminated |
GAM | K981935 |
| Aug 17, 2017 | Ethicon, Inc. Coated VICRYL RAPIDETM (Polyglactin 910) Suture Terminated |
GAM | K033746 |
| May 3, 2017 | Medtronic SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 Terminated |
GAM | None listed |
| May 3, 2017 | Medtronic CUSTOM SUTURE PACK; Item Number: US1540 and US1614 Terminated |
GAM | None listed |
| May 3, 2017 | Medtronic USPACK-SUTURE KIT; Item Number: US1672 Terminated |
GAM | None listed |
| May 3, 2017 | Medtronic Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312 Terminated |
GAM | None listed |
| May 3, 2017 | Medtronic Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M Terminated |
GAM | K000037 |
| May 3, 2017 | Medtronic Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number:
1 Terminated |
GAM | K934738 |
| May 3, 2017 | Medtronic Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433 Terminated |
GAM | K990951 |
| May 3, 2017 | Medtronic Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404;
POLSORB 1 18 VIO PRECUT 122J; Item Terminated |
GAM | K963253 |
| Feb 2, 2017 | CP Medical Inc PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile, Product Codes L923, L459, L493, L762, L463, L922, L495, L463, L497, L494, L493 Open, Classified |
GAM | K072229 |
| Aug 1, 2016 | Aesculap Implant Systems LLC Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture Terminated |
GAM | K031286 |
| Jul 23, 2015 | Silhouette Lift, Inc. Silhouette Lift brochure
Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position. Terminated |
GAM | K060414 |
| May 7, 2014 | Teleflex Medical Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical.
Indicated for use in soft tissue approximation. Terminated |
GAM | K930738 |
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