FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
K Number: K934320
·
Decision Feb 16, 1994
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
10
Applicant Total
18
Review Days
166
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Basic Information
- Device Name
- MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION
- K Number
- K934320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4100
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mentor O & O, Inc.
- Date Received
- September 3, 1993
- Decision Date
- February 16, 1994
- Product Code
- HQR
- 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 |
|---|---|---|---|
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Mentor O & O, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955245 | MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM | Feb 12, 1996 | Substantially Equivalent |
| K912904 | MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM | Jun 11, 1992 | Substantially Equivalent |
| K915340 | MENTOR HORIZON LOW VISION MAGNIFIER | Mar 30, 1992 | Substantially Equivalent |
| K910637 | MENTOR(R) SUR-E-TROL(R) | May 13, 1991 | Substantially Equivalent |
| K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 | May 2, 1991 | Substantially Equivalent |
| K903878 | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT | Nov 5, 1990 | Substantially Equivalent |
| K895010 | MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE | Sep 11, 1989 | Substantially Equivalent |
| K890622 | SURG-E-TROL SYSTEM I AND SYSTEM II | May 4, 1989 | Substantially Equivalent |
| K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR | Apr 17, 1989 | Substantially Equivalent |
| K881001 | MENTOR WET-FIELD*II COAGULATOR | May 13, 1988 | Substantially Equivalent |