510(k) K000037 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
MONOFILAMENT BIOSYN SUTURE
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, Mar 30, 2000 |
| Received | Jan 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Feb 19, 2020 | Covidien LLC Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201 Terminated |
GAM | None listed |
| May 3, 2017 | Medtronic Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.