Secret Line
Secret Line is an absorbable PDO suture supplied with a needle for dermatological soft tissue approximation. Bidirectional barbs along the monofilament engage tissue and retain the closure…
Secret Line is an absorbable PDO suture supplied with a needle for dermatological soft tissue approximation. Bidirectional barbs along the monofilament engage tissue and retain the closure without a surgical knot.
The assembly includes a straight hollow cannula-type needle, needle cap, hub and sponge. The polydioxanone suture is dyed violet using D&C Violet No. 2.
Listed Item
Secret Line (Absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2.
Suture Scope
The device is supplied ethylene oxide sterilized for single use. Its barbed design is used where an absorbable suture is appropriate for dermatological approximation. It is not intended for body-cavity procedures or for lifting and supporting tissue.
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 | Hyundae Meditech Co., Ltd., South Korea |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| Establishment | Manufacturer |
| 510(k) | K242571 |
| Record published | 2026-06-17 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 25 °C |
| Packaging | Pouch of 12 |
| Sizes | Length 150 to 160 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FCL18100C160 | Length 160 mm | In distribution |
| FCL2190G150 | Length 150 mm | 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 |
|---|---|
| K242571 | 2024-09-27 |
| K240389 | 2024-03-27 |
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.