Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control— 510(k) K232157
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K232157 for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control, Substantially Equivalent on 2023-08-18. Applicant: Stryker Corporation.
Clearance details
- Applicant
- Stryker Corporation
- Product code
- Code GCJ
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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.