Stryker SDC3 HD Information Management System with Wireless Device Control Capability— 510(k) K160332
Substantially EquivalentStryker Endoscopy
FDA 510(k) clearance K160332 for Stryker SDC3 HD Information Management System with Wireless Device Control Capability, Substantially Equivalent on 2016-05-18. Applicant: Stryker Endoscopy.
Clearance details
- Applicant
- Stryker Endoscopy
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.