510(k) DEN240007
- Device
- BioHealx Anal Fistula Device
- Applicant
- Signum Surgical Limited
- 510(k) number
- DEN240007
- Product code
- QML
- Decision
- Unknown (DENG)
- Decision date
- 2024-07-01
- Date received
- 2024-02-02
- Regulation
- 878.4835
- Classification name
- Anal Fistula Closure Device
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Moshe Zilversmit
- Address
- Galway Harbour Enterprise Par, New Docks, The Docks Galway IE H91 NNY6 H91 NNY6
FDA Registration Numbers#
- 3038193698
- 3015615781
- 3008889904
Source Documents#
510(k) summary PDF not indicated by FDA