Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
FDA 510(k) K232157 · Stryker Corporation
510(k) numberK232157
Submission
- Device name
- Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- Applicant
- Stryker Corporation
San Jose, CA, US - Received
- July 20, 2023
- Decision date
- August 18, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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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Questions and answers
When was Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control cleared by the FDA?
Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (K232157) received a 510(k) decision of Substantially Equivalent on August 18, 2023, 29 days after the submission was received.
What is the product code of K232157?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.