FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHURE GRIP TYING FORCEPS
K Number: K844129
·
Decision Nov 21, 1984
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
18
Review Days
29
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Basic Information
- Device Name
- SHURE GRIP TYING FORCEPS
- K Number
- K844129
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Mentor O & O, Inc.
- Date Received
- October 23, 1984
- Decision Date
- November 21, 1984
- Product Code
- HNR
- 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 |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | FDA class 1 | Ophthalmic |
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| 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 |