FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
QEVO System with KINEVO 900
K Number: K170667
·
Decision Aug 18, 2017
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
92
Applicant Total
45
Review Days
165
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
- QEVO System with KINEVO 900
- K Number
- K170667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1480
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carl Zeiss Meditec, AG
- Date Received
- March 6, 2017
- Decision Date
- August 18, 2017
- Product Code
- GWG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GWG), ordered by most recent decision date.
Precision S 4K Sinuscope
FDA 510(k)
FDA Class 2
·Neurology
Hydro Irrigation System
FDA 510(k)
FDA Class 2
·Neurology
HJY VisualNext 3D Endoscopic Vision System
FDA 510(k)
FDA Class 2
·Neurology
AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)
FDA 510(k)
FDA Class 2
·Neurology
cCeLL - In vivo
FDA 510(k)
FDA Class 2
·Neurology
Digital ClarusScope System, Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Carl Zeiss Meditec, AG
| K Number | Device Name | ||
|---|---|---|---|
| K241174 | INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) | Jan 10, 2025 | Substantially Equivalent |
| K233911 | VISULAS combi | Sep 6, 2024 | Substantially Equivalent |
| K240215 | BLUE 400; BLUE 400 S | Jun 28, 2024 | Substantially Equivalent |
| K233421 | RESCAN 700 | Mar 8, 2024 | Substantially Equivalent |
| K232944 | CALLISTO eye | Dec 21, 2023 | Substantially Equivalent |
| K232159 | QEVO System | Sep 21, 2023 | Substantially Equivalent |
| K231676 | CALLISTO eye | Aug 28, 2023 | Substantially Equivalent |
| K230858 | QUATERA 700 | Jul 31, 2023 | Substantially Equivalent |
| K213527 | FORUM | Aug 15, 2022 | Substantially Equivalent |
| K211346 | BLUE 400 | Jul 22, 2022 | Substantially Equivalent |