ProteXsure Safety Capsule System
FDA 510(k) clearance K152597 · decided 2016-06-08
Clearance details
- K-number
- K152597
- Device name
- ProteXsure Safety Capsule System
- Applicant
- Starcap Medical, LLC ( Dba Prism Medical & Design)
- Decision
- Substantially Equivalent
- Date received
- 2015-09-11
- Decision date
- 2016-06-08
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Parkland, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.