FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
K Number: K874997
·
Decision Apr 13, 1988
Classifications
1
FEI Numbers
80
Registration Numbers
81
Same Product Code
19
Applicant Total
64
Review Days
133
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Basic Information
- Device Name
- PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
- K Number
- K874997
- 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
- HNY
- 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 |
|---|---|---|---|
| HNY | Cystotome | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNY), ordered by most recent decision date.
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PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME
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PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
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PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
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PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
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 |