FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANTERIOR CAPSULECTOMY CYSTITOME
K Number: K840659
·
Decision Mar 16, 1984
Classifications
1
FEI Numbers
80
Registration Numbers
81
Same Product Code
19
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- ANTERIOR CAPSULECTOMY CYSTITOME
- K Number
- K840659
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Sharpoint, Inc.
- Date Received
- February 15, 1984
- Decision Date
- March 16, 1984
- 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 DISPOSABLE BLUNT IRRIGATING CYSTOTOME
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Sharpoint, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863595 | COATED SUTURE NEEDLE | Oct 24, 1986 | Substantially Equivalent |
| K861947 | SURGICAL KNIFE | Jun 6, 1986 | Substantially Equivalent |
| K840764 | EAR KNIVES | May 21, 1984 | Substantially Equivalent |
| K840855 | CORNEAL SCLERAL LANCE | May 9, 1984 | Substantially Equivalent |
| K840660 | POSTERIOR CAPSULOTOMY CYSTITOME | Mar 16, 1984 | Substantially Equivalent |
| K830522 | STAINLESS STEEL SUTURE 316L | Mar 31, 1983 | Substantially Equivalent |
| K822112 | OPHTHALMIC KNIFE | Aug 10, 1982 | Substantially Equivalent |
| K821440 | V LANCE | Jun 14, 1982 | Substantially Equivalent |