FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
K Number: K961524
·
Decision May 16, 1996
Classifications
1
FEI Numbers
80
Registration Numbers
81
Same Product Code
19
Applicant Total
1
Review Days
24
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
- STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
- K Number
- K961524
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sterilab, Inc.
- Date Received
- April 22, 1996
- Decision Date
- May 16, 1996
- 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.
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 DISPOSABLE BLUNT IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic