SDC3 HD Information Management System with Wireless Device Control Capability
FDA 510(k) clearance K210584 · decided 2021-03-18
Clearance details
- K-number
- K210584
- Device name
- SDC3 HD Information Management System with Wireless Device Control Capability
- Applicant
- Stryker
- Decision
- Substantially Equivalent
- Date received
- 2021-02-26
- Decision date
- 2021-03-18
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.