FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
3DSCOPE
K Number: K923160
·
Decision Dec 10, 1992
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
22
Applicant Total
1
Review Days
164
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
- 3DSCOPE
- K Number
- K923160
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4160
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Surgical Technologies Corp.
- Date Received
- June 29, 1992
- Decision Date
- December 10, 1992
- Product Code
- FWF
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FWF | Camera, Television, Endoscopic, Without Audio | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWF), ordered by most recent decision date.
FLEXISCOPE, MODELS 50MH AND 50 MHC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VES 1501-M
FDA 510(k)
FDA Class 1
·General, Plastic Surgery