Panels › General, Plastic Surgery › Product code GAP · Class 2
Suture, Nonabsorbable, Silk
Regulation 878.5030
0510(k)s in 12 months (41 all time)
0recalls in 12 months (28 all time)
28recalls that name a 510(k)
Top companies in GAP
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien | 1 | 24 |
| United States Surgical, A Division of Tyco Healthc | 5 | 0 |
| Ethicon, Inc. | 0 | 3 |
| M/s. Meril Endo Surgery Private Limited. | 2 | 0 |
| Safepath Medical, Inc. | 2 | 0 |
| Surgical Specialties, Inc. | 2 | 0 |
| Advance Suture, Inc. | 1 | 0 |
| Aesculap, Inc. | 1 | 0 |
| Alcon Laboratories | 1 | 0 |
| Arc Medical Supplies (Beijing) Co, Ltd. | 1 | 0 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
| Jun 10, 2020 | Ethicon, Inc. PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes
EH7457G
EH7983G
FV768
FV769
FV7771
U7058
U7059
W1782
W1784
W1819
W1820
W818
W819
W870 Open, Classified |
GAP | K946173 |
| Dec 18, 2018 | Ethicon, Inc. PERMA-HAND Silk Suture Size 5, Black 30" (75cm)
Double Armed LR Needles, Product Code 485T
Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation Terminated |
GAP | K946173 |
| Jan 9, 2015 | Ethicon, Inc. Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA. Terminated |
GAP | K946173 |
| May 7, 2014 | Teleflex Medical Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P.
Indicated for use in soft tissue approximation. Terminated |
GAP | K930738 |
| Jul 15, 2011 | Covidien LP Syneture Ti-Cron 0 5X18" BLUE T-40/HGS-22 D-TACH,
non-absorbable polyester sutures
Material 8886337962
Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use Terminated |
GAP | K930591 |
| Jul 15, 2011 | Covidien LP Syneture Ti-Cron 2 BLUE 5X18" HGS-22
non-absorbable polyester sutures
Material 8886337282
Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardio Terminated |
GAP | K930591 |
| Jul 15, 2011 | Covidien LP Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach
non-absorbable polyester sutures
Material 8886337272
Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the Terminated |
GAP | K930591 |
| Jul 15, 2011 | Covidien LP Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach
non-absorbable polyester sutures
Material 8886326062
Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the Terminated |
GAP | K930591 |
| Jul 15, 2011 | Covidien LP Syneture Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH
non-absorbable polyester sutures
Material 8886325962
Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use i Terminated |
GAP | K930591 |
| Jul 15, 2011 | Covidien LP Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT
non-absorbable polyester sutures
Material 8886300162
Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the card Terminated |
GAP | K930591 |
| Jul 15, 2011 | Covidien LP Syneture Surgilon 4/0 BLK 5X18 CV-22 D*TACH JLDT
non-absorbable braided nylon sutures
Material 8886195332J
Surgilon is intended for use in general soft tissue approximation and/or ligation, including Terminated |
GAP | K981582 |
| Jul 15, 2011 | Covidien LP Syneture Surgilon 0 Black 5X18 T-3/GS-23 D-TACH
non-absorbable braided nylon sutures
Material 8886199362
Surgilon is intended for use in general soft tissue approximation and/or ligation, including u Terminated |
GAP | K981582 |
| Jul 15, 2011 | Covidien LP Syneture Surgilon 0 Blk 5X18 T-12/GS-21 D-TACH
non-absorbable braided nylon sutures
Material 8886196262
Surgilon is intended for use in general soft tissue approximation and/or ligation, including Terminated |
GAP | K981582 |
| Jul 15, 2011 | Covidien LP Syneture Surgilon 0 Blk 3X18 CE-10/C-16
non-absorbable braided nylon sutures
Material 8886193662
Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in t Terminated |
GAP | K981582 |
| Jul 15, 2011 | Covidien LP Syneture Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH
non-absorbable braided nylon sutures
Material 8886191022
Surgilon is intended for use in general soft tissue approximation and/or ligation, includ Terminated |
GAP | K981582 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
| 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 | K981128 |
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