STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
FDA 510(k) clearance K100852 · decided 2010-05-06
Clearance details
- K-number
- K100852
- Device name
- STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
- Applicant
- Stryker Communications
- Decision
- Substantially Equivalent
- Date received
- 2010-03-26
- Decision date
- 2010-05-06
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- OCS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Flower Mound, TX, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.