FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SELF-RETAINING BICANALICULUS INTUBATON SET II
K Number: K130375
·
Decision Dec 4, 2013
Classifications
1
FEI Numbers
19
Registration Numbers
20
Same Product Code
30
Applicant Total
3
Review Days
293
Basic Information
- Device Name
- SELF-RETAINING BICANALICULUS INTUBATON SET II
- K Number
- K130375
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION)
- Date Received
- February 14, 2013
- Decision Date
- December 4, 2013
- Product Code
- OKS
- 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 |
|---|---|---|---|
| OKS | Lacrimal Stents And Intubation Sets | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OKS), ordered by most recent decision date.
Ritleng®+ and Ritleng®+ PVP
FDA 510(k)
FDA Unclassified
·Unknown
LacriJet®
FDA 510(k)
FDA Unclassified
·Unknown
Lacriflow CL
FDA 510(k)
FDA Unclassified
·Unknown
Nunchaku
FDA 510(k)
FDA Unclassified
·Unknown
Oasis Lacrimal Intubation Set
FDA 510(k)
FDA Unclassified
·Unknown
DacryoCATH
FDA 510(k)
FDA Unclassified
·Unknown