Visitec Silicone Retinal Implants/Explants
FDA 510(k) K945172 · Visitec Co.
510(k) numberK945172
Submission
- Device name
- Visitec Silicone Retinal Implants/Explants
- Applicant
- Visitec Co.
Sarasota, FL, US - Received
- October 21, 1994
- Decision date
- January 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code HQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K980816 | Retinal Detachment Implants, Including Bands, Strips (Rails) and SpongesHQX · Traditional | Fci Ophthalmics, Inc. | 09/18/1998SE |
| 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 |
| 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 |
More from Oculo Plastik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
| K923645 | Visitec Aspirating SyringeFMF · Traditional | 09/30/1992SE |
Questions and answers
When was Visitec Silicone Retinal Implants/Explants cleared by the FDA?
Visitec Silicone Retinal Implants/Explants (K945172) received a 510(k) decision of Substantially Equivalent on January 17, 1995, 88 days after the submission was received.
What is the product code of K945172?
The FDA product code is HQX – Implant, Orbital, Extra-Ocular, a Class II (moderate risk) device regulated under 21 CFR 886.3340.