FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
CONFIDENT SURGERY SUITE 300, MODEL CSS300
K Number: K101887
·
Decision Mar 22, 2011
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
29
Applicant Total
3
Review Days
259
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
- CONFIDENT SURGERY SUITE 300, MODEL CSS300
- K Number
- K101887
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1320
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Surgiceye GmbH
- Date Received
- July 6, 2010
- Decision Date
- March 22, 2011
- Product Code
- IZD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IZD), ordered by most recent decision date.
DECLIPSESPECT LAPAROSCOPY
FDA 510(k)
FDA Class 1
·Radiology
DECLIPSESPECT VIEWER
FDA 510(k)
FDA Class 1
·Radiology
HANDHELD GAMMA FINDER (HGF)
FDA 510(k)
FDA Class 1
·Radiology
MODIFICATION TO GAMMA GUIDANCE SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
FDA 510(k)
FDA Class 1
·Radiology
NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
FDA 510(k)
FDA Class 1
·Radiology