Perma-Hand
Black Braided Siliconized Silk, Nonabsorbable Surgical Suture
4manufacturers in China registered for this device type
231catalogue numbers in this listing
3recalls on this code
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 | Ethicon, Inc., United States |
|---|---|
| FDA product code | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K946173 |
| Record published | 2015-09-01 |
| Record revised | 2026-05-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not use if package is opened or damaged |
| Packaging | Box of 36, box of 12, box of 24 |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 709H | In distribution | |
| K572H | In distribution | |
| C014D | In distribution | |
| 765G | In distribution | |
| 640G | In distribution | |
| K581H | In distribution | |
| 624H | In distribution | |
| D6563 | In distribution | |
| D3851 | In distribution | |
| C018D | In distribution | |
| D9551 | In distribution | |
| K534H | In distribution | |
| W782H | In distribution | |
| A305H | In distribution | |
| K890ZH | In distribution | |
| SA86G | In distribution | |
| D10136 | In distribution | |
| W586H | In distribution | |
| 1675H | In distribution | |
| K831H | In distribution | |
| D8370 | In distribution | |
| 789G | In distribution | |
| 768G | In distribution | |
| A302H | In distribution | |
| SA87G | In distribution | |
| 783G | In distribution | |
| 1677G | In distribution | |
| SA65H | In distribution | |
| K881H | In distribution | |
| 632G | In distribution | |
| D6022 | In distribution | |
| SA63H | In distribution | |
| K802H | In distribution | |
| 1687G | In distribution | |
| K964H | In distribution | |
| K832H | In distribution | |
| A306H | In distribution | |
| D2484 | In distribution | |
| 684H | In distribution | |
| K870H | In distribution | |
| 1679H | In distribution | |
| 443H | In distribution | |
| C004D | In distribution | |
| K533H | In distribution | |
| SA77G | In distribution | |
| D1882 | In distribution | |
| 1639G | In distribution | |
| A307H | In distribution | |
| D9119 | In distribution | |
| 629G | In distribution | |
| 619H | In distribution | |
| 424H | In distribution | |
| N267H | In distribution | |
| D2194 | In distribution | |
| K882H | In distribution | |
| W578H | In distribution | |
| 1925G | In distribution | |
| 7733G | In distribution | |
| 682G | In distribution | |
| D4168 | In distribution | |
| C012D | In distribution | |
| P1691H | In distribution | |
| C013D | In distribution | |
| K873H | In distribution | |
| K952H | In distribution | |
| C003D | In distribution | |
| 622H | In distribution | |
| SA74H | In distribution | |
| A183H | In distribution | |
| W509G | In distribution | |
| 1732G | In distribution | |
| 684G | In distribution | |
| C0125 | In distribution | |
| 737G | In distribution | |
| D7703 | In distribution | |
| 7734G | In distribution | |
| 1588H | In distribution | |
| 714G | In distribution | |
| C084D | In distribution | |
| SA7H | In distribution | |
| D10004 | In distribution | |
| N266H | In distribution | |
| K570H | In distribution | |
| SA66G | In distribution | |
| D8904 | In distribution | |
| D7328 | In distribution | |
| D9442 | In distribution | |
| D7794 | In distribution | |
| D8552 | In distribution | |
| C053D | In distribution | |
| 641G | In distribution | |
| D8467 | In distribution | |
| 486H | In distribution | |
| C027D | In distribution | |
| 735G | In distribution | |
| K891H | In distribution | |
| M104T | In distribution | |
| D7877 | In distribution | |
| K883H | In distribution | |
| W604G | In distribution | |
| C045D | In distribution | |
| K845H | In distribution | |
| LA53G | In distribution | |
| K834H | In distribution | |
| 580H | In distribution | |
| 673H | In distribution | |
| W723H | In distribution | |
| C022D | In distribution | |
| SA84H | In distribution | |
| A187H | In distribution | |
| K942H | In distribution | |
| SA10G | In distribution | |
| 485T | In distribution | |
| M3T | In distribution | |
| A182H | In distribution | |
| D9580 | In distribution | |
| SA5H | In distribution | |
| SA11G | In distribution | |
| 591H | In distribution | |
| 1678H | In distribution | |
| W328H | In distribution | |
| 678H | In distribution | |
| 1780G | In distribution | |
| 685H | In distribution | |
| D4655 | In distribution | |
| D6623 | In distribution | |
| SA83H | In distribution | |
| K880H | In distribution | |
| SA73H | In distribution | |
| 3622 | In distribution | |
| K889H | In distribution | |
| 766G | In distribution | |
| K801H | In distribution | |
| LA55G | In distribution | |
| 1676G | In distribution | |
| 707G | In distribution | |
| K580H | In distribution | |
| D9747 | In distribution | |
| 679H | In distribution | |
| SA9G | In distribution | |
| 621H | In distribution | |
| D9984 | In distribution | |
| K871H | In distribution | |
| C042D | In distribution | |
| 1984G | In distribution | |
| N271H | In distribution | |
| W775H | In distribution | |
| A184H | In distribution | |
| M72T | In distribution | |
| 675H | In distribution | |
| D9489 | In distribution | |
| 680H | In distribution | |
| K852H | In distribution | |
| K846H | In distribution | |
| C054D | In distribution | |
| W666H | In distribution | |
| C041D | In distribution | |
| D9892 | In distribution | |
| 482T | In distribution | |
| K809H | In distribution | |
| D9474 | In distribution | |
| D8600 | In distribution | |
| C021D | In distribution | |
| SA8H | In distribution | |
| 677G | In distribution | |
| K843H | In distribution | |
| 683G | In distribution | |
| 623H | In distribution | |
| D9659 | In distribution | |
| 18515G | In distribution | |
| EH7552H | In distribution | |
| 734G | In distribution | |
| C0135 | In distribution | |
| C046D | In distribution | |
| K945G | In distribution | |
| SA64H | In distribution | |
| M13T | In distribution | |
| 706G | In distribution | |
| D7525 | In distribution | |
| SA75H | In distribution | |
| 590H | In distribution | |
| 639G | In distribution | |
| D9991 | In distribution | |
| A303H | In distribution | |
| A304H | In distribution | |
| SA85H | In distribution | |
| SA76G | In distribution | |
| D8986 | In distribution | |
| K844H | In distribution | |
| K835H | In distribution | |
| D7793 | In distribution | |
| DC460 | In distribution | |
| K833H | In distribution | |
| A185H | In distribution | |
| D8342 | In distribution | |
| D8085 | In distribution | |
| K954H | In distribution | |
| D6533 | In distribution | |
| C0145 | In distribution | |
| C016D | In distribution | |
| 1689H | In distribution | |
| 736G | In distribution | |
| D8264 | In distribution | |
| 1684G | In distribution | |
| SA6H | In distribution | |
| N272H | In distribution | |
| K872H | In distribution | |
| 413H | In distribution | |
| 786G | In distribution | |
| A186H | In distribution | |
| 685G | In distribution | |
| C017D | In distribution | |
| LA54G | In distribution | |
| DC645 | In distribution | |
| 769G | In distribution | |
| 7729G | In distribution | |
| M14T | In distribution | |
| K9634G | In distribution | |
| 1690H | In distribution | |
| 583H | In distribution | |
| 780G | In distribution | |
| K890H | In distribution | |
| D8551 | In distribution | |
| 423H | In distribution | |
| C026D | In distribution | |
| K571H | In distribution | |
| 678G | In distribution | |
| Q809H | Withdrawn | |
| Q706H | Withdrawn | |
| 10Q07 | Withdrawn | |
| 10Q06 | 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 |
| 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 |
| Rtmed | Shandong Haidike Medical Products Co., Ltd. | 34 |
Showing 12 of 205. All products under Suture, Nonabsorbable, Silk
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ethicon, Inc. | 510(k) number | 2020-06-10 | Class II | Nonconforming Material/Component | Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years | 99,612 eaches | |
| Ethicon, Inc. | 510(k) number | 2019-04-19 | Class II | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | 1296 eaches | 2021-02-05 |
| Ethicon, Inc. | 510(k) number | 2019-04-19 | Class II | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot | 36 eaches | 2021-02-05 |
| Ethicon, Inc. | 510(k) number | 2018-12-18 | Class II | Packaging process control | The sutures inside the packaging are not the same size or type as indicated on the label. | 840 | 2020-05-29 |
| Ethicon, Inc. | 510(k) number | 2014-10-17 | Class II | Other | Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products. | 2,508 each | 2015-08-14 |
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.