AMI Custom Crafted FCL | 21g X 90mm
Catalogue number L-FTN2192G, listed by Feeltech Co., Ltd., South Korea, under Suture, Surgical, Absorbable, Polydioxanone. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Feeltech Co., Ltd., South Korea |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172602 |
| Record published | 2021-02-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Inbox of 10, carton box of 300 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| L-FTN2192G | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeDIOX | Demetech Corp. | 994 |
| Monoplus | B Braun Surgical SA | 697 |
| PDS | Ethicon, Inc. | 430 |
| Wego-PDO Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 180 |
| Stratafix | Ethicon, Inc. | 172 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 74 |
| PDO Max Threads | Max Pdo Inc | 64 |
| Assufil Monofilamento | Assut Europe | 50 |
| LES Encres | Meditime Co., Ltd. | 42 |
| DemeDIOX Barbed | Demetech Corp. | 40 |
| Viola | Meditime Co., Ltd. | 36 |
| Stratafix Spiral | Surgical Specialties México, S. de R.L. de C.V. | 34 |
Showing 12 of 292. All products under Suture, Surgical, Absorbable, Polydioxanone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251414 | 2025-10-20 |
| K250107 | 2025-10-15 |
| K172602 | 2018-11-14 |
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 |
|---|---|---|---|
| N18331 | 1986-06-06 | PDS SUTURE (DYED) | Ethicon, 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.