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510(k) K232157

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control by Stryker Corporation — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2023
Date Received
July 20, 2023
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

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).

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