FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
K Number: K023400
·
Decision Aug 22, 2003
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
38
Applicant Total
13
Review Days
317
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Basic Information
- Device Name
- FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
- K Number
- K023400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fci Ophthalmics, Inc.
- Date Received
- October 9, 2002
- Decision Date
- August 22, 2003
- Product Code
- HPZ
- 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPZ), ordered by most recent decision date.
EZYPOR
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SILICONE SPHERES
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ORBITAL RECONSTRUCTIVE IMPLANT II
FDA 510(k)
FDA Class 2
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EYE SPHERES
FDA 510(k)
FDA Class 2
·Ophthalmic
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 |
| K041869 | SELF RETAINING BICANALICULUS INTUBATION SET | Nov 18, 2004 | Substantially Equivalent |
| K023758 | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | Sep 17, 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 |