McKesson
SUTURE 4-0 Silk, Black Braided, 4-0 U.S.P. (1.5 Metric) 18"/46cm Non-Absorbable Surgical Suture, DS18 Reverse Cutting 3/8 Circle 18 mm
4manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| 510(k) | K981128 |
| Record published | 2016-12-09 |
| Record revised | 2021-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, box of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S683G | In distribution | |
| S683GX | In distribution | |
| S622H | In distribution |
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 |
| Deknatel | Teleflex Medical LLC | 109 |
| 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 |
Showing 12 of 205. All products under Suture, Nonabsorbable, Silk
Recalls Naming This Product
14 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2024-01-25 | Class II | Process control | One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound dehiscence, hemorrhage, | 36 total, OUS distribution only | |
| Covidien | 510(k) number | 2023-12-21 | Class II | Process control | Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood | 46,812 US; 68,976 OUS | |
| Covidien | UDI-DI | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 12732 units | |
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 271800 units | |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 2014-02-10 | |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 5640 units | 2014-02-10 |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 528 units | 2014-02-10 |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 3600 units | 2014-02-10 |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 3360 units | 2014-02-10 |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 19848 units | 2014-02-10 |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 31080 units | 2014-02-10 |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 4080 units | 2014-02-10 |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 960 units | 2014-02-10 |
| Covidien | 510(k) number | 2011-06-03 | Not classified | Equipment maintenance | Potential for the sterile barrier to be breached compromising the sterility of the product | 768 units | 2014-02-10 |
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.