510(k) K946173 ยท GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jan 9, 1995 |
| Received | Dec 19, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2026 | Ethicon, LLC ETHILON Nylon Suture, Product Code 697G Open, Classified |
GAQ | None listed |
| Oct 14, 2026 | Ethicon, LLC PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H Open, Classified |
GAQ | None listed |
| Apr 3, 2025 | Ethicon Endo Surgery, LLC ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH Open, Classified |
NEW | None listed |
| Feb 4, 2025 | Ethicon, LLC PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic an Open, Classified |
GAW | None listed |
| 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 | None listed |
| Apr 19, 2019 | Ethicon, Inc. ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1
Product Code: X425H
Product Usage:
ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or li Terminated |
GAQ | None listed |
| Apr 19, 2019 | Ethicon, Inc. ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX
Product Code: X865W
Product Usage:
ETHIBOND EXCEL Suture is intended for use in general soft tissue approximation and/or lig Terminated |
GAQ | None listed |
| 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 | None listed |
| Jun 25, 2015 | Ethicon, Inc. Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019.
Fast absorbing surgical gut Terminated |
GAL | None listed |
| Jan 9, 2015 | Ethicon, Inc. Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA. Terminated |
GAP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.