Force DFX Suture Loop -Xtreme™ DFX34XSL
Force DFX Suture Loop -Xtreme™ DFX34XSL (DFX0034S) is a Class II device made by Dunamis Medical LLC, cleared under FDA 510(k) K150327 on 29 Jun 2015 and listed in FDA GUDID since 10 Apr 2025 (UDI-DI 00850052601294), 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 | GUDID listing | Number00850052601294 | Date10 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK150327 | Date29 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 00850052601294
- FDA 510(k) database K150327
Across registries
- FDA 510(k) K150327 decided 29 Jun 2015 Active
- FDA GUDID UDI-DI 00850052601294 listed 10 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K150327
- Listed FDA GUDID 00850052601294
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Force DFX Suture Loop -Xtreme™
- Generic name
- Polyolefin/fluoropolymer suture, multifilament
- Model / Ref / Catalog
- DFX34XSL, DFX0034S
- Primary DI / UDI-DI
- 00850052601294
- 510(k) Number
- FDA product code
- GAT
- GMDN term
- Polyolefin/fluoropolymer suture, multifilament
- Device class
- Class II
- Regulation number
- 878.5000
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Polyolefin/fluoropolymer suture, multifilament.