BioHealx Anal Fistula Device
FDA 510(k) clearance DEN240007 · decided 2024-07-01
Clearance details
- K-number
- DEN240007
- Device name
- BioHealx Anal Fistula Device
- Applicant
- Signum Surgical Limited
- Decision
- Unknown
- Date received
- 2024-02-02
- Decision date
- 2024-07-01
- Days to decision
- 150 days
- Clearance type
- Direct
- Product code
- QML
- Device class
- 2
- Regulation number
- 878.4835
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.