Viola
The FDA summary identifies VIOLA as a barbed surgical suture made of absorbable polydioxanone. The suture is described as sterile and intended for soft-tissue approximation where absorbable…
The FDA summary identifies VIOLA as a barbed surgical suture made of absorbable polydioxanone.
The suture is described as sterile and intended for soft-tissue approximation where absorbable suture is appropriate.
Construction
The filing says the suture does not need surgical knots after tissue approximation and lists USP sizes 0 through 4-0, with attached stainless-steel needles. It has 85 cog-shaped barbs along the suture, each described as 0.567 mm in size.
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 | Meditime Co., Ltd., South Korea |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K190264 |
| Record published | 2024-06-04 |
| Record revised | 2026-04-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 75, box of 125, box of 50, box of 150, box of 25 |
| Distribution end date | 2026-04-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19G 50mm, USP : 2/70mm | In distribution | |
| 20G 70mm, USP : 2-0/140mm | In distribution | |
| 19G 100mm, USP : 0/200mm | In distribution | |
| 20G 100mm, USP : 2-0/200mm | In distribution | |
| 19G 100mm, USP : 0/200mm | In distribution | |
| 19G 70mm, USP : 0/140mm | In distribution | |
| 20G 70mm, USP : 2-0 / 135mm | Withdrawn | |
| DVMXR27060C-50090X | Withdrawn | |
| DVAGR19100L-00170X | Withdrawn | |
| USP : 2/570mm | Withdrawn | |
| 20G 100mm, USP : 2-0/165mm | Withdrawn | |
| DVMXS29025C-60030X | Withdrawn | |
| 19G 38mm, USP : 0/40mm | Withdrawn | |
| DVNXR19038L-60040X | Withdrawn | |
| DVMXR29038C-60050X | Withdrawn | |
| DVMXR27038C-50050X | Withdrawn | |
| DVMXS29038C-60050X | Withdrawn | |
| DVMXB23050L-60070X | Withdrawn | |
| DVMXS29060C-60090X | Withdrawn | |
| DVTXS26038C-70050X | Withdrawn | |
| 130mm, USP : 2/480mm | Withdrawn | |
| 130mm, USP : 2/570mm | Withdrawn | |
| DVMXS26060C-50090X | Withdrawn | |
| DVMXS26038C-50050X | Withdrawn | |
| 110mm, USP : 2-0/440mm | Withdrawn | |
| DVTXS26060C-70090X | Withdrawn | |
| DVMXR29025C-60030X | Withdrawn | |
| DVAGR18100L-02170X | Withdrawn | |
| DVMXR30025C-60030X | Withdrawn | |
| DVMXR30025B-60030X | Withdrawn | |
| 19G 100mm, USP : 0/165mm | Withdrawn | |
| 110mm, USP : 2-0/290mm | Withdrawn | |
| 110mm, USP : 2/480mm | Withdrawn | |
| 130mm, USP : 2/390mm | Withdrawn | |
| 110mm, USP : 2/320mm | Withdrawn | |
| DVNXR19060L-60080X | Withdrawn |
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 |
| Stratafix Spiral | Surgical Specialties México, S. de R.L. de C.V. | 34 |
| Unify PDO Surgical Sutures | Applied Dental, Inc. | 34 |
Showing 12 of 292. All products under Suture, Surgical, Absorbable, Polydioxanone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190264 | 2019-08-15 |
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.