FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SELF RETAINING BICANALICULUS INTUBATION SET
K Number: K041869
·
Decision Nov 18, 2004
Classifications
1
FEI Numbers
20
Registration Numbers
21
Same Product Code
30
Applicant Total
13
Review Days
132
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
- SELF RETAINING BICANALICULUS INTUBATION SET
- K Number
- K041869
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fci Ophthalmics, Inc.
- Date Received
- July 9, 2004
- Decision Date
- November 18, 2004
- 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
Other Clearances by Fci Ophthalmics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K061404 | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE | Aug 7, 2006 | Substantially Equivalent |
| K061398 | SNUG PLUG PUNCTUM PLUG | Jul 11, 2006 | Substantially Equivalent |
| K023758 | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | Sep 17, 2003 | Substantially Equivalent |
| K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | Aug 22, 2003 | Substantially Equivalent |
| K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | Feb 26, 2003 | Substantially Equivalent |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | Apr 19, 2000 | Substantially Equivalent |
| K991238 | FCI CRAWFORD PROBE INTUBATION SETS | Jul 8, 1999 | Substantially Equivalent |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Sep 18, 1998 | Substantially Equivalent |
| K980822 | TITANIUM PEG SYSTEM | Jul 9, 1998 | Substantially Equivalent |
| K964774 | PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS | Dec 20, 1996 | Substantially Equivalent |