Synergy Insufflation FM134
by W.O.M. World of Medicine GmbH
Synergy Insufflation FM134 is a Class II device made by W.O.M. World of Medicine GmbH, cleared under FDA 510(k) K153513 on 4 Mar 2016 and listed in FDA GUDID since 10 Aug 2016 (UDI-DI 04056702002824), 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 | Number04056702002824 | Date10 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153513 | Date4 Mar 2016 | StatusActive |
Official records
- AccessGUDID record 04056702002824
- FDA 510(k) database K153513
Across registries
- FDA 510(k) K153513 decided 4 Mar 2016 Active
- FDA GUDID UDI-DI 04056702002824 listed 10 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K153513
- Listed FDA GUDID 04056702002824
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Synergy Insufflation
- Generic name
- Laparoscopic insufflator
- Model / reference
- FM134
- Primary DI / UDI-DI
- 04056702002824
- 510(k) Number
- FDA product code
- HIF
- GMDN term
- Laparoscopic insufflator
- Device class
- Class II
- Regulation number
- 884.1730
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Laparoscopic insufflator.