ARC-EX System— 510(k) K251821
Substantially EquivalentOnward Medical, Inc.
FDA 510(k) clearance K251821 for ARC-EX System, Substantially Equivalent on 2025-11-14. Applicant: Onward Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Onward Medical, Inc.
- Product code
- Code SDO
- Device class
- Class 2
- Regulation
- 21 CFR 890.5851
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code SDO
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