Deknatel
Silk Black Braided Size 3-0 18" DE-1 Needle
4manufacturers in China registered for this device type
109catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K930739 |
| Record published | 2015-10-16 |
| Record revised | 2025-01-16 (version 12) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: none |
| Packaging | Box of 36, sleeve, box of 12, box of 6, sleeve of 6 |
| Sizes | Length 45 to 75 cm; length 18 to 60 in; length 3.63 mm; width 1.98 mm; height 2.87 mm |
| Distribution end date | 2017-06-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN025445 | SILK /Needle C-2 Size-2-0 | In distribution |
| IPN026760 | Length 45 cm | In distribution |
| IPN027369 | SILK /Needle Size-2 | In distribution |
| IPN025471 | Length 30 in | In distribution |
| IPN025503 | Length 30 in | In distribution |
| IPN000931 | Suture length 18″, Needle length.942″ | In distribution |
| IPN025470 | Length 30 in | In distribution |
| IPN027364 | Length 45 cm | In distribution |
| IPN025497 | Length 30 in | In distribution |
| IPN025446 | Length 75 cm | In distribution |
| IPN027299 | Length 75 cm | In distribution |
| IPN025472 | Length 30 in | In distribution |
| IPN027359 | SILK /Needle C-2 Size-2-0 | In distribution |
| IPN026757 | SILK /Needle KC-6 Size-1 | In distribution |
| IPN025472 | Length 30 in | In distribution |
| IPN025307 | SILK /Needle C-13 Size-3-0 | In distribution |
| IPN026761 | Length 75 cm | In distribution |
| IPN025473 | Length 30 in | In distribution |
| IPN027357 | SILK /Needle C-2 Size-4-0 | In distribution |
| IPN025492 | Length 24 in | In distribution |
| IPN025486 | Length 60 in | In distribution |
| IPN025469 | Length 30 in | In distribution |
| IPN025499 | Length 30 in | In distribution |
| IPN025445 | Length 75 cm | In distribution |
| IPN025489 | Length 18 in | In distribution |
| IPN025501 | Length 18 in | In distribution |
| IPN027358 | Length 75 cm | In distribution |
| IPN026985 | SILK /Needle CE-1 Size-1 | In distribution |
| IPN025500 | Length 30 in | In distribution |
| IPN026870 | Length 3.63 mm | In distribution |
| IPN025467 | Length 30 in | In distribution |
| IPN027357 | SILK /Needle C-2 Size-4-0 | In distribution |
| IPN026767 | Length 75 cm | In distribution |
| IPN025496 | Length 30 in | In distribution |
| IPN026984 | SILK /Needle CE-1 Size-1 | In distribution |
| IPN025490 | Length 18 in | In distribution |
| IPN027351 | Length 75 cm | In distribution |
| IPN027351 | SILK /Needle CE-3 Size-0 | In distribution |
| IPN025464 | Length 24 in | In distribution |
| IPN027356 | Length 75 cm | In distribution |
| IPN025498 | Length 30 in | In distribution |
| IPN026772 | SILK /Needle C-2, C-2 Size-1 | In distribution |
| IPN027362 | Length 75 cm | In distribution |
| IPN027369 | SILK /Needle Size-2 | In distribution |
| IPN025308 | SILK /Needle C-13 Size-3-0 | In distribution |
| IPN025469 | Length 30 in | In distribution |
| IPN027352 | Length 45 cm | In distribution |
| IPN025486 | Length 60 in | In distribution |
| IPN026984 | Length 60 cm | In distribution |
| IPN025464 | Length 24 in | In distribution |
| IPN025479 | Length 30 in | In distribution |
| IPN025444 | SILK /Needle C-2 Size-3-0 | In distribution |
| IPN025446 | SILK /Needle C-2 Size-0 | In distribution |
| IPN025491 | Length 24 in | In distribution |
| IPN002973 | SILK /Needle Size-2 | In distribution |
| IPN027275 | SILK /Needle C-2, C-2 Size-2-0 | In distribution |
| IPN027298 | SILK /Needle C-2, C-2 Size-2-0 | In distribution |
| IPN025307 | SILK /Needle C-13 Size-3-0 | In distribution |
| IPN027362 | SILK /Needle T-4 Size-3-0 | In distribution |
| IPN025474 | Length 30 in | In distribution |
| IPN025306 | SILK /Needle C-2 Size-2-0 | In distribution |
| IPN025492 | Length 24 in | In distribution |
| IPN025493 | Length 24 in | In distribution |
| IPN004565 | SILK /Needle Size-2 | In distribution |
| IPN026985 | Length 60 cm | In distribution |
| IPN025498 | Length 30 in | In distribution |
| IPN025462 | Length 24 in | In distribution |
| IPN027352 | SILK /Needle C-2 Size-2-0 | In distribution |
| IPN025496 | Length 30 in | In distribution |
| IPN025500 | Length 30 in | In distribution |
| IPN025471 | Length 30 in | In distribution |
| IPN025447 | Length 75 cm | In distribution |
| IPN027355 | SILK /Needle C-2 Size-2-0 | In distribution |
| IPN026870 | Height 2.87 mm | In distribution |
| IPN026761 | Length 75 cm | In distribution |
| IPN027275 | SILK /Needle C-2, C-2 Size-2-0 | In distribution |
| IPN025493 | Length 24 in | In distribution |
| IPN025489 | Length 18 in | In distribution |
| IPN025488 | Length 18 in | In distribution |
| IPN026767 | STAINLESS STEEL /Needle K-60, K-60 Size-5 | In distribution |
| IPN025476 | Length 30 in | In distribution |
| IPN026757 | SILK /Needle KC-6 Size-1 | In distribution |
| IPN025476 | Length 30 in | In distribution |
| IPN025467 | Length 30 in | In distribution |
| IPN025306 | Length 45 cm | In distribution |
| IPN025491 | Length 24 in | In distribution |
| IPN025473 | Length 30 in | In distribution |
| IPN025474 | Length 30 in | In distribution |
| IPN025457 | SILK /Needle SE-1 Size-3-0 | In distribution |
| IPN025481 | Length 18 in | In distribution |
| IPN025499 | Length 30 in | In distribution |
| IPN027358 | SILK /Needle C-2 Size-3-0 | In distribution |
| IPN025479 | Length 30 in | In distribution |
| IPN025494 | Length 24 in | In distribution |
| IPN027355 | Length 45 cm | In distribution |
| IPN025444 | Length 75 cm | In distribution |
| IPN025501 | Length 18 in | In distribution |
| IPN025503 | Length 30 in | In distribution |
| IPN025470 | Length 30 in | In distribution |
| IPN025494 | Length 24 in | In distribution |
| IPN027359 | Length 75 cm | In distribution |
| IPN025488 | Length 18 in | In distribution |
| IPN025447 | Length 75 cm | In distribution |
| IPN026760 | Length 45 cm | In distribution |
| IPN027356 | Length 75 cm | In distribution |
| IPN025457 | SILK /Needle SE-1 Size-3-0 | In distribution |
| IPN025497 | Length 30 in | Withdrawn |
| IPN000930 | Suture length 18″, Needle length.781″ | Withdrawn |
| IPN025490 | Length 18 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeSILK | Demetech Corp. | 1,198 |
| Silkam | B Braun Surgical SA | 632 |
| Wego-Silk Non-absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 404 |
| Sofsilk | Covidien LP | 319 |
| Perma-Hand | Ethicon, Inc. | 231 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 100 |
| Mani Sutures Silk | Mani, Inc. | 75 |
| Suture, Nonabsorbable, Silk | C P Medical Inc. | 48 |
| Sutumed | Unilene S.A.C. | 44 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 36 |
| Silk | Resorba Medical GmbH | 35 |
| Rtmed | Shandong Haidike Medical Products Co., Ltd. | 34 |
Showing 12 of 205. All products under Suture, Nonabsorbable, Silk
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-03-11 | Class II | Employee error | Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use. | 32,271 ea. | 2017-08-14 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N80989 | 1989-08-01 | SILK SUTURES | Lukens Corp. |
| N84348 | 1989-06-16 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK | Deknatel, Inc. |
| N85143 | 1987-04-03 | SUTURES | Sharpoint, Inc. |
| N11397 | 1982-12-08 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | Ethicon, Inc. |
| N84047 | 1982-07-16 | SILK NONABSORBABLE SUTURES, USP | Davis & Geck, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.