510(k) K120556 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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| Applicant | Riverpoint Medical, Portland OR, US |
| Decision | Substantially Equivalent, May 23, 2012 |
| Received | Feb 24, 2012 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K120556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2020 | Riverpoint Medical, LLC Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 Terminated |
GAM | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 18" P-14 Cutting, Product Number: SV6830, UDI: 20884521152349 - Product Usage: indicated for use in soft tissue approximation of t Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 18" P-24, Product Number: SV9911G, UDI: 20884521149776 - Product Usage: indicated for use in soft tissue approximation of the ski Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation of t Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - Product Usage: indicated for use in soft tissue approximation of the ski Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 1 Undyed 36" GS-12, Cutting Product Number: CV486, UDI: 20884521150925 - Product Usage: indicated for use in soft tissue approximation of th Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779
- Product Usage: indicated for use in soft tissue approximation of the skin Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117 - Product Usage: indicated for use in soft tissue approximation of the skin and m Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 6/0 Undyed 30" P-10 Cutting, Product Number: SV4893, UDI: 20884521151717 - Product Usage: indicated for use in soft tissue approximation of Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - Product Usage: indicated for use in soft tissue approximation of t Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 18" P-12 Cutting, Product Number: SV496G, UDI: 20884521149691 - Product Usage: indicated for use in soft tissue approximation of Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20884521149363 - Product Usage: indicated for use in soft tissue approximation of th Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Product Usage: indicated for use in soft tissue approximation of the Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 5/0 Undyed 30" CV-23 Taper, Product Number: CV1213, UDI: 20884521150758 - Product Usage: indicated for use in soft tissue approximation of t Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 18" P-12 Cut, Product Number: SV496, UDI: 20884521184258 - Product Usage: indicated for use in soft tissue approximation of the s Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" P-14, Product Number: SVP2251, UDI: 20884521177380 - Product Usage: indicated for use in soft tissue approximation of the ski Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 20884521151588 - Product Usage: indicated for use in soft tissue approximat Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 18" PC-10, Product Number: SV835G, UDI: 20884521149721
- Product Usage: indicated for use in soft tissue approximation of the ski Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 36" KV-34, TaperCutting Product Number: CV916, UDI: 20884521153032 - Product Usage: indicated for use in soft tissue approximatio Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Usage: indicated for use in soft tissue approximation of the skin a Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" C-12 Cutting, Product Number: SV2295, UDI: 20884521151397 - Product Usage: indicated for use in soft tissue approximation of Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 0 Undyed 36" GS-11 Cutting CV4731, UDI: 20884521151359 - Product Usage: indicated for use in soft tissue approximation of the skin and mucos Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, whe Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288
- Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731
- Product Usage: indicated for use in soft tissue approximation of the skin and muco Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595
- Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, wh Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295
- Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usage: indicated for use in soft tissue approximation of the skin an Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 18" P-12 Cutting SV497G, UDI: 20884521149707 - Product Usage: indicated for use in soft tissue approximation of the skin and muco Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 2/0 Undyed 30" GS-20 CV9975G, UDI: 20884521149585 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, wh Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 4/0 Undyed 30" P-12 Cutting SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucos Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" CV-25 Taper CV3110, UDI: 20884521150918 - Product Usage: indicated for use in soft tissue approximation of the skin and mucos Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" P-14 Cutting SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucos Terminated |
GAM | None listed |
| Aug 3, 2020 | Riverpoint Medical, LLC Velosorb Fast Braided Absorbable Suture:
Covidien Velosorb 3/0 Undyed 30" C-13 Cutting SV2298, UDI: 20884521151021 - Product Usage: indicated for use in soft tissue approximation of the skin and muco Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.