InstaFAN
FDA 510(k) clearance K251542 · decided 2025-07-18
Clearance details
- K-number
- K251542
- Device name
- InstaFAN
- Applicant
- Onepass Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-20
- Decision date
- 2025-07-18
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- ODG
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Katzrin, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.