Pds Polydioxanone Mesh
by Ethicon Inc.
510(k) K844228
Pds Polydioxanone Mesh is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K844228 on 24 Jan 1985, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844228 | Date24 Jan 1985 | StatusActive |
Official records
- FDA 510(k) database K844228
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FTM
- FDA applicant
- ETHICON, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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- EluPro Antibiotic-Eluting BioEnvelope by Boston Scientific
- DEXON 'S' POLYGLYCOLIC ACID MESH by Davis & Geck, Inc.
- THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX by Implex Corp.