PIXEL 3 SYSTEM
FDA 510(k) clearance DEN130015 · decided 2014-05-09
Clearance details
- K-number
- DEN130015
- Device name
- PIXEL 3 SYSTEM
- Applicant
- Gauss Surgical, Inc.,
- Decision
- Unknown
- Date received
- 2013-02-04
- Decision date
- 2014-05-09
- Days to decision
- 459 days
- Clearance type
- Direct
- Product code
- PBZ
- Device class
- 2
- Regulation number
- 880.2750
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Los Altos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.