Silastic Scleral Sponge II W/Circling BD
FDA 510(k) K800140 · Dow Corning Corp. Healthcare Industries Materials
510(k) numberK800140
Submission
- Device name
- Silastic Scleral Sponge II W/Circling BD
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
Mchenry, IL, US - Received
- January 21, 1980
- Decision date
- March 3, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Oculo Plastik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853186 | Silastic Inflatable Bone Plug H.P.LZN · Traditional | 09/24/1985SE |
| K844637 | Whiteside Acrylic Cement Spacer SleeveLTC · Traditional | 06/19/1985SE |
| K850255 | Dow Corning Wright Titanium Wrist Joint Grommet · Traditional | 05/01/1985SE |
| K843995 | Tf-Ii Hip ProsthesisKWL · Traditional | 04/23/1985SE |
| K842559 | Whiteside Ortholoc Total Hip FemoralKWL · Traditional | 12/20/1984SE |
| K840357 | Ssa Hip ProsthesisJDI · Traditional | 02/17/1984SE |
| K831479 | Metal-Backed Acetabular CupDXQ · Traditional | 06/15/1983SE |
| K812864 | Silastic Voice ProsthesisEWL · Traditional | 11/24/1981SE |
| K812053 | Silastic Hemi Wrist Implant H.P. (Rad.)KXE · Traditional | 08/18/1981SE |
| K811679 | Silastic Tendon Passer H.P.HWQ · Traditional | 07/10/1981SE |
Questions and answers
When was Silastic Scleral Sponge II W/Circling BD cleared by the FDA?
Silastic Scleral Sponge II W/Circling BD (K800140) received a 510(k) decision of Substantially Equivalent on March 3, 1980, 42 days after the submission was received.
What is the product code of K800140?
The FDA product code is HQX – Implant, Orbital, Extra-Ocular, a Class II (moderate risk) device regulated under 21 CFR 886.3340.