510(k) K200310
K200310 is an FDA 510(k) premarket notification submitted by Stryker for the device "1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality". The FDA issued a decision of Substantially Equivalent on Mar 6, 2020. The device falls under product code GCJ (Laparoscope, General & Plastic Surgery), a Class II device regulated under 21 CFR 876.1500. Stryker has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 2020
- Date Received
- Feb 6, 2020
- Clearance Type
- Special
- 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).