FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATARACT DIAMOND KNIFE
K Number: K863725
·
Decision Oct 31, 1986
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
53
Applicant Total
5
Review Days
38
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Basic Information
- Device Name
- CATARACT DIAMOND KNIFE
- K Number
- K863725
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Medical Technology Development Corp.
- Date Received
- September 23, 1986
- Decision Date
- October 31, 1986
- Product Code
- HNN
- 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 |
|---|---|---|---|
| HNN | Knife, Ophthalmic | FDA class 1 | Ophthalmic |
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Other Clearances by Medical Technology Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K941488 | DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER | Nov 30, 1994 | Substantially Equivalent |
| K862315 | FYODOROV COLLAGEN CORNEAL SHIELD | Jan 7, 1987 | Substantially Equivalent |
| K863727 | FIXATION INSTRUMENTS | Oct 31, 1986 | Substantially Equivalent |
| K863726 | INSTRUMENT STERILIZATION TRAY | Oct 14, 1986 | Substantially Equivalent |