PDO Max Threads PM18100L-SC
PDO Max Threads PM18100L-SC is a polyester suture (FDA Class II; FDA product code NEW, Suture, Surgical, Absorbable, Polydioxanone) made by Max Pdo Inc, cleared under FDA 510(k) K190245 on 4 Jun 2019 and listed in FDA GUDID since 12 Dec 2020 (UDI-DI 00850018324182), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850018324182 | Date12 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190245 | Date4 Jun 2019 | StatusActive |
Official records
- AccessGUDID record 00850018324182
- FDA 510(k) database K190245
Across registries
- FDA 510(k) K190245 decided 4 Jun 2019 Active
- FDA GUDID UDI-DI 00850018324182 listed 12 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K190245
- Listed FDA GUDID 00850018324182
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PDO Max Threads
- Generic name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial
- Model / Ref / Catalog
- PM18100L-SC
- Primary DI / UDI-DI
- 00850018324182
- 510(k) Number
- FDA product code
- NEW
- GMDN term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial
- Device class
- Class II
- Regulation number
- 878.4840
- GUDID distribution status
- In Commercial Distribution
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