A.C.S® (Alcon Closure System)
Suture - Needle Type CU-5,Black Twisted Silk(BTS), Suture Size 9-0, Suture Length 12,Double Armed
4manufacturers in China registered for this device type
16catalogue numbers in this listing
1510(k) clearance
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 | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| 510(k) | K760158 |
| Record published | 2015-10-24 |
| Record revised | 2024-03-21 (version 5) |
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, manufacturing date |
| Packaging | Box of 12 |
| Sizes | Length 12 to 30 in; height 12 in |
| Distribution end date | 2021-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8065184701 | Length 18 in | In distribution |
| 8065193601 | Length 18 in | In distribution |
| 8065184601 | Length 18 in | In distribution |
| 8065195601 | Length 18 in | In distribution |
| 8065193501 | Length 18 in | In distribution |
| 8065192401 | Length 12 in | Withdrawn |
| 8065186001 | Length 18 in | Withdrawn |
| 8065205301 | Length 18 in | Withdrawn |
| 8065187601 | Length 18 in | Withdrawn |
| 8065184901 | Length 30 in | Withdrawn |
| 8065184501 | Length 12 in | Withdrawn |
| 8065196301 | Height 12 in | Withdrawn |
| 8065217701 | Length 18 in | Withdrawn |
| 8065187501 | Length 18 in | Withdrawn |
| 8065193401 | Length 12 in | Withdrawn |
| 8065184801 | Length 18 in | Withdrawn |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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K760158 | 1976-08-19 |
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.