Affirm 400
FDA 510(k) clearance K251286 · decided 2026-01-21
Clearance details
- K-number
- K251286
- Device name
- Affirm 400
- Applicant
- Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
- Decision
- Substantially Equivalent
- Date received
- 2025-04-25
- Decision date
- 2026-01-21
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- QFX
- Device class
- 2
- Regulation number
- 882.4950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BLUE 400; BLUE 400 S (K240215) | Carl Zeiss Meditec, AG | 2024-06-28 |
| Myriad SPECTRA Light Source (K232567) | Nico Corporation | 2024-03-14 |
| BLUE 400 (K211346) | Carl Zeiss Meditec, AG | 2022-07-22 |
| Leica FL400 (DEN180024) | Leica Microsystems (Schweiz) AG | 2019-03-28 |
Recalls involving this device
No recalls on record reference this clearance.