FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
K Number: K872312
·
Decision Jul 15, 1987
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
3
Review Days
92
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
- MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
- K Number
- K872312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Allergan Humphrey
- Date Received
- April 14, 1987
- Decision Date
- July 15, 1987
- Product Code
- HQE
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQE), ordered by most recent decision date.
UniVit HE, UniVit UHS
FDA 510(k)
FDA Class 2
·Ophthalmic
Cetus system, Cetus probe
FDA 510(k)
FDA Class 2
·Ophthalmic
Bi-Blade Vitrectomy Cutter
FDA 510(k)
FDA Class 2
·Ophthalmic
CONSTELLATION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
VERSAVIT
FDA 510(k)
FDA Class 2
·Ophthalmic
PROCARE PLUS VITRECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic