510(k) K981582 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
SURGILON, DERMALON, & OPHTHALON
| Applicant | Davis & Geck, Inc., Hazlewood MO, US |
| Decision | Substantially Equivalent, Jul 13, 1998 |
| Received | May 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981582
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2026 | Covidien, LP Dermalon
88861757-31 DERMALON* 4-0 BLU 75CM C13
88861757-31
88861799-31 DERMALON* 4-0 BLU 75CM C14
88861799-31 Open, Classified |
GAR | None listed |
| Jan 29, 2024 | Covidien LP Surgilon Braided Nylon sutures:
88861919-31 SURGILON* 4-0 BLK 7X75CMPCT
88861919-41 SURGILON* 3-0 BLK 7X75CMPCT
88861919-51 SURGILON* 2-0 BLK 7X75CMPCT
88861919-71 SURGILON* 1 BLK 7X75CM PCT Open, Classified |
GAR | None listed |
| Feb 25, 2023 | Covidien, LP Dermalon Monofilament Nylon Suture:
(1) 88861741-11 DERMALON* 6-0 BLU 45CM C1
(2) 88861747-11 DERMALON* 6-0 BLU 45CM C12
(3) 88861749-24 DERMALON* 5-0 BLU 45CM P13
(4) 88861756-11 DERMALON* 6-0 BLU 4 Open, Classified |
GAR | None listed |
| Feb 25, 2023 | Covidien, LP Surgilon Braided Nylon suture
Product Description:
88861883-51 SURGILON* 2-0 BLK 75CM C16
88861915-71 SURGILON* 1 BLK 75CM GS11
88861919-31 SURGILON* 4-0 BLK 7X75CMPCT
88861919-41 SURGILON* 3-0 BLK 7X Open, Classified |
GAR | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.