510(k) K222079
K222079 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control". The FDA issued a decision of Substantially Equivalent on Oct 11, 2022. The device falls under product code GCJ (Laparoscope, General & Plastic Surgery), a Class II device regulated under 21 CFR 876.1500. Stryker Endoscopy has 102 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 11, 2022
- Date Received
- Jul 15, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, General & Plastic Surgery
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
- 510(k)
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).