Retinal Detachment Implants, Including Bands, Strips (Rails) and Sponges
FDA 510(k) K980816 · Fci Ophthalmics, Inc.
510(k) numberK980816
Submission
- Device name
- Retinal Detachment Implants, Including Bands, Strips (Rails) and Sponges
- Applicant
- Fci Ophthalmics, Inc.
Marshfield Hills, MA, US - Received
- March 3, 1998
- Decision date
- September 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HQX – Implant, Orbital, Extra-Ocular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3340
- Specialty
- Ophthalmic
- Implant
- Yes
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|---|---|---|---|
| K023481 | Microvision Scleral Buckling ComponentsHQX · Traditional | Microvision, Inc. | 01/08/2003SE |
| K983581 | Ocu-Guard and Ocu-Guard SuppleHQX · Special | Bio-Vascular, Inc. | 11/06/1998SE |
| K963219 | Retinal Detachment Implants; Including Bans, Strips, Tires, Sleeves, Cords and SpongesHQX · Traditional | Fci Ophthalmics, Inc. | 10/28/1996SE |
| K950806 | Solid Dilicone Implants, Sdilicone Sponge ImplantsHQX · Traditional | Mira, Inc. | 06/05/1996SE |
| K950599 | Stors Scleral Sponge II (Lincoff Design)HQX · Traditional | Storz Ophthalmics, Inc. | 03/02/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | Visitec Co. | 01/17/1995SE |
| K902308 | Tamcenan Ocular Explants and BandsHQX · Traditional | Tamcenan Corp. | 06/19/1990SE |
| K901002 | O'Donnell, Socket Reconstruction ProsthesesHQX · Traditional | Oculo Plastik, Inc. | 05/22/1990SE |
| K900929 | Putterman-Scott, Socket Reconstruction BilateralHQX · Traditional | Oculo Plastik, Inc. | 05/18/1990SE |
| K900930 | Spivey-Allen Orbital Floor ImplantHQX · Traditional | Oculo Plastik, Inc. | 05/15/1990SE |
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| K041869 | Self Retaining Bicanaliculus Intubation SetOKS · Traditional | 11/18/2004SE |
| K023758 | Becker Transnasal Lacrimal (Intubation Sets)OKS · Traditional | 09/17/2003SE |
| K023400 | Fci Mesh Wrapped Bioceramic Orbital ImplantHPZ · Traditional | 08/22/2003SE |
| K030054 | Disposable Vitrectomy Sets, Disposable Virectomy LensesHJK · Traditional | 02/26/2003SE |
| K992294 | Bioceramic Orbital ImplantHPZ · Traditional | 04/19/2000SE |
| K991238 | Fci Crawford Probe Intubation SetsOKS · Traditional | 07/08/1999SE |
| K980822 | Titanium Peg SystemMQU · Traditional | 07/09/1998SE |
| K964774 | Punctum Plugs & Ready-Set Punctal PlugsLZU · Traditional | 12/20/1996SE |
Questions and answers
When was Retinal Detachment Implants, Including Bands, Strips (Rails) and Sponges cleared by the FDA?
Retinal Detachment Implants, Including Bands, Strips (Rails) and Sponges (K980816) received a 510(k) decision of Substantially Equivalent on September 18, 1998, 199 days after the submission was received.
What is the product code of K980816?
The FDA product code is HQX – Implant, Orbital, Extra-Ocular, a Class II (moderate risk) device regulated under 21 CFR 886.3340.