FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
K-SOL
K Number: K844249
·
Decision Apr 30, 1985
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
20
Applicant Total
12
Review Days
179
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Basic Information
- Device Name
- K-SOL
- K Number
- K844249
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Cilco, Inc.
- Date Received
- November 2, 1984
- Decision Date
- April 30, 1985
- Product Code
- LYX
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LYX | Media, Corneal Storage | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYX), ordered by most recent decision date.
XTRA4
FDA 510(k)
FDA Unclassified
·Unknown
Cornisol
FDA 510(k)
FDA Unclassified
·Unknown
Independent Corneal Viewing Chamber (IVC-21)
FDA 510(k)
FDA Unclassified
·Unknown
Eusol-C
FDA 510(k)
FDA Unclassified
·Unknown
Cornea Cold
FDA 510(k)
FDA Unclassified
·Unknown
LIFE4C
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Cilco, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861334 | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | May 2, 1986 | Substantially Equivalent |
| K854969 | CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) | Feb 27, 1986 | Substantially Equivalent |
| K843319 | CILCO I/A SURGICAL PACK | Feb 14, 1985 | Substantially Equivalent |
| K843992 | CILCOR OPHTHALMIC INSTRUMENTS | Nov 21, 1984 | Substantially Equivalent |
| K843447 | CILCO DIAMOND KNIFE | Oct 5, 1984 | Substantially Equivalent |
| K841099 | OCTOPUS 500/500E | Jun 19, 1984 | Substantially Equivalent |
| K840475 | CYSTOTOME, 140-S | Apr 5, 1984 | Substantially Equivalent |
| K832405 | OPTHALMIC ENDOSCOPE | Nov 21, 1983 | Substantially Equivalent |
| K827371 | CILCO ASCAN | Jul 9, 1982 | Substantially Equivalent |
| K820933 | CILCO I/A HANDPIECE | Jun 14, 1982 | Substantially Equivalent |