FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRISMA DISPOSABLE MVR/STILETTO BLADE
K Number: K874979
·
Decision Apr 13, 1988
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
53
Applicant Total
64
Review Days
133
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Basic Information
- Device Name
- PRISMA DISPOSABLE MVR/STILETTO BLADE
- K Number
- K874979
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Advanced Surgical Products, Inc.
- Date Received
- December 2, 1987
- Decision Date
- April 13, 1988
- 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 Advanced Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K030926 | FAST THROW STAINLESS STEEL SURGICAL SUTURE | Jul 21, 2003 | Substantially Equivalent |
| K895800 | ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR | Jan 22, 1990 | Substantially Equivalent |
| K896754 | I/A HANDPIECE | Jan 11, 1990 | Substantially Equivalent |
| K896305 | MULTI-USE I/A HANDPIECE | Dec 18, 1989 | Substantially Equivalent |
| K884557 | ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE | May 12, 1989 | Substantially Equivalent |
| K884556 | DREYER CURVED ENDOILLUMINATOR | Feb 28, 1989 | Substantially Equivalent |
| K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | Feb 17, 1989 | Substantially Equivalent |
| K884347 | MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN | Dec 27, 1988 | Substantially Equivalent |
| K883857 | FIBEROPTIC WIRE PICK LIGHTPIPE | Sep 29, 1988 | Substantially Equivalent |
| K883858 | FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE | Sep 29, 1988 | Substantially Equivalent |