FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
K Number: K980816
·
Decision Sep 18, 1998
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
15
Applicant Total
13
Review Days
199
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
- RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
- K Number
- K980816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3340
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fci Ophthalmics, Inc.
- Date Received
- March 3, 1998
- Decision Date
- September 18, 1998
- Product Code
- HQX
- 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 |
|---|---|---|---|
| HQX | Implant, Orbital, Extra-Ocular | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQX), ordered by most recent decision date.
MICROVISION SCLERAL BUCKLING COMPONENTS
FDA 510(k)
FDA Class 2
·Ophthalmic
OCU-GUARD AND OCU-GUARD SUPPLE
FDA 510(k)
FDA Class 2
·Ophthalmic
RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
FDA 510(k)
FDA Class 2
·Ophthalmic
SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
FDA 510(k)
FDA Class 2
·Ophthalmic
STORS SCLERAL SPONGE II (LINCOFF DESIGN)
FDA 510(k)
FDA Class 2
·Ophthalmic
VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS
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 |
| 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 |
| K980822 | TITANIUM PEG SYSTEM | Jul 9, 1998 | Substantially Equivalent |
| K964774 | PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS | Dec 20, 1996 | Substantially Equivalent |