FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASMOTOM AUTOMATED TREPHINE SYSTEM
K Number: K013151
·
Decision Dec 14, 2001
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
1
Review Days
85
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
- ASMOTOM AUTOMATED TREPHINE SYSTEM
- K Number
- K013151
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4070
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bkg Opthalmics USA, Inc.
- Date Received
- September 20, 2001
- Decision Date
- December 14, 2001
- Product Code
- HRG
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HRG | Engine, Trephine, Accessories, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRG), ordered by most recent decision date.
AUTOMATED CORNEAL TREPHINE
FDA 510(k)
FDA Class 1
·Ophthalmic
ULTRATHIN/SP LENS
FDA 510(k)
FDA Class 1
·Ophthalmic
SCANLAN VASCU-STATT II
FDA 510(k)
FDA Class 1
·Ophthalmic
TREPHINE BLADES-VARIOUS MODELS
FDA 510(k)
FDA Class 1
·Ophthalmic
(MICRO-KERATRON, MICRO DUCT TREPHINE)
FDA 510(k)
FDA Class 1
·Ophthalmic