EdgeFlow Gel Pad
FDA 510(k) clearance K252337 · decided 2026-04-24
Clearance details
- K-number
- K252337
- Device name
- EdgeFlow Gel Pad
- Applicant
- Edgecare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-28
- Decision date
- 2026-04-24
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- MUI
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.