FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
K Number: K875001
·
Decision Apr 13, 1988
Classifications
1
FEI Numbers
80
Registration Numbers
81
Same Product Code
19
Applicant Total
64
Review Days
131
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
- K Number
- K875001
- 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 4, 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.
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
FDA 510(k)
FDA Class 1
·Ophthalmic
CYSTOTOMES/KNIFES
FDA 510(k)
FDA Class 1
·Ophthalmic
PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
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 |