PDO
2 catalogue numbers from M303, listed by C P Medical Inc., under Suture, Surgical, Absorbable, Polydioxanone. 2 manufacturers in China are registered for 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 | C P Medical Inc. |
|---|---|
| FDA product code | NEW |
| Device type | Suture, Surgical, Absorbable, Polydioxanone |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4840 |
| 510(k) | K013274 |
| Record published | 2016-02-23 |
| Record revised | 2021-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M303 | In distribution | |
| M463 | 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
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| C P Medical Inc. | 510(k) number | 2009-01-02 | Not classified | Nonconforming Material/Component | The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch. | 13632 sutures | 2011-12-13 |
| C P Medical Inc. | 510(k) number | 2008-09-17 | Not classified | Vendor change control | Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised. | 1684/12 pcs. Boxes (1628/12 pcs. Boxes to veterinary market, | 2010-09-28 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-09-22 | Class II | Nonconforming Material/Component | CP Medical Inc. is recalling five lots of Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture for failing to meet the minimum tensile strength as dictated by USP was not met over the length of the product’s shelf lif | 74 boxes /12 sutures per box; plus an additional 13 sutures | 2015-02-17 |
| 2014-04-23 | Class II | Employee error | CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength. | US distribution:4 boxes/ 12 sutures per box (48 total); Outs | 2014-09-12 |
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.