FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Video Laparoscope, Video Processor, Light Source
K Number: K192918
·
Decision Feb 20, 2020
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
64
Review Days
128
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Basic Information
- Device Name
- Video Laparoscope, Video Processor, Light Source
- K Number
- K192918
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fujifilm Corporation
- Date Received
- October 15, 2019
- Decision Date
- February 20, 2020
- 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 |
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| K251386 | ECHELON Synergy | Sep 17, 2025 | Substantially Equivalent |
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