510(k) K981128 ยท GAP Suture, Nonabsorbable, Silk
SOFSILK SUTURE
| Applicant | United States Surgical, A Division of Tyco Healthc, Norwalk CT, US |
| Decision | Substantially Equivalent, May 11, 1998 |
| Received | Mar 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981128
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2024 | Covidien, LP Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation. Open, Classified |
GAP | None listed |
| Jan 29, 2024 | Covidien LP Sofsilk Braided Silk sutures:
CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36
GS-831 SOFSILK* 4-0 BLK 75CM V20 X36
S-176 SOFSILK* 0 BLK 12X45CM PCT X24
S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36
S-184 SOFSILK* 3- Open, Classified |
GAP | None listed |
| Feb 25, 2023 | Covidien, LP Sofsilk Coated Braided Silk Suture Product Description
CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211
CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490
CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562
GS- Open, Classified |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 0 18" BLACK GS-21 DT
non-absorbable braided nylon sutures
CS10M
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 3/0 18" BLACK CV-25 DT
non-absorbable silk sutures
GS33M
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophth Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH
non-absorbable silk sutures
GS43M
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascul Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 4/0 18" BLACK CV-22 DT
non-absorbable silk sutures
GS44M
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, opht Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 4/0 18" BLACK CV-22 DT
non-absorbable silk sutures
GS46M
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophth Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH
non-absorbable silk sutures
GS62M
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 3/0 18" BLACK V-20 DT
non-absorbable braided nylon sutures
GS63M
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascula Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 2/0 30" BLACK V-20 DT
non-absorbable braided nylon sutures
GS66M
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascul Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE
non-absorbable braided nylon sutures
S194
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardi Terminated |
GAP | None listed |
| Jul 15, 2011 | Covidien LP Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE
non-absorbable braided nylon sutures
S196
Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the card Terminated |
GAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.