Eroxon
FDA 510(k) clearance DEN220078 · decided 2023-06-09
Clearance details
- K-number
- DEN220078
- Device name
- Eroxon
- Applicant
- Futura Medical Developments Limited
- Decision
- Unknown
- Date received
- 2022-10-21
- Decision date
- 2023-06-09
- Days to decision
- 231 days
- Clearance type
- Direct
- Product code
- QWW
- Device class
- 2
- Regulation number
- 876.5021
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Guildford, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.