FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Connected OR Hub with Device and Voice Control
K Number: K192172
·
Decision Sep 9, 2019
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
92
Review Days
28
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Connected OR Hub with Device and Voice Control
- K Number
- K192172
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker
- Date Received
- August 12, 2019
- Decision Date
- September 9, 2019
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tech-Image Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TroKit Laparoscope Lens Wiper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Inno-Port Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Stryker
| K Number | Device Name | ||
|---|---|---|---|
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | Sep 20, 2023 | Substantially Equivalent |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | May 19, 2023 | Substantially Equivalent |
| K230754 | L12 LED Light Source with AIM | Apr 11, 2023 | Substantially Equivalent |
| K230605 | 1788 4K Camera System with Advanced Imaging Modality | Mar 31, 2023 | Substantially Equivalent |
| K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | Feb 23, 2023 | Substantially Equivalent |
| K222130 | 1688 4K Camera System with Advanced Imaging Modality | Aug 19, 2022 | Substantially Equivalent |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Aug 11, 2022 | Substantially Equivalent |
| K221611 | 780 nm L11 LED Light Source with AIM | Jun 29, 2022 | Substantially Equivalent |
| K221217 | SPY Laparoscope | Jun 17, 2022 | Substantially Equivalent |
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable | May 25, 2022 | Substantially Equivalent |