FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
ULYSS Multi View Sinuscope
K Number: K153701
·
Decision Sep 9, 2016
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
1
Review Days
261
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
- ULYSS Multi View Sinuscope
- K Number
- K153701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sopro-Comeg GmbH
- Date Received
- December 23, 2015
- Decision Date
- September 9, 2016
- Product Code
- EOB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EOB), ordered by most recent decision date.
Hydro Irrigation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ENTity USB Videoscope System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Outlook Surgical Versa One System (8900139)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Portare System (FA-001)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat