Ocu-Guard and Ocu-Guard Supple
FDA 510(k) K983581 · Bio-Vascular, Inc.
510(k) numberK983581
Submission
- Device name
- Ocu-Guard and Ocu-Guard Supple
- Applicant
- Bio-Vascular, Inc.
St. Paul, MN, US - Received
- October 13, 1998
- Decision date
- November 6, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| K023481 | Microvision Scleral Buckling ComponentsHQX · Traditional | Microvision, Inc. | 01/08/2003SE |
| 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 |
| K900930 | Spivey-Allen Orbital Floor ImplantHQX · Traditional | Oculo Plastik, Inc. | 05/15/1990SE |
More from Oculo Plastik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002233 | Bvi SlingPAJ · Traditional | 10/13/2000SE |
| K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…FTM · Traditional | 02/22/2000SE |
| K983602 | CV Peri-Guard and Vascu-GuardDXZ · Special | 11/12/1998SE |
| K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…FTM · Special | 10/09/1998SE |
| K981624 | Flo-ThruDXC · Traditional | 08/04/1998SE |
| K982282 | Dura-Guard - Dural Repair PatchGXQ · Special | 07/30/1998SE |
| K971726 | CV Peri-Guard - Cardiovascular PatchDXZ · Traditional | 04/10/1998SE |
| K973706 | Dura-Guard-Dural Repair PatchGXQ · Traditional | 12/24/1997SE |
| K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapMTZ · Traditional | 12/16/1997SE |
| K971048 | Peri-Strips Dry - Staple Line ReinforcementFTM · Traditional | 05/09/1997SE |
Questions and answers
When was Ocu-Guard and Ocu-Guard Supple cleared by the FDA?
Ocu-Guard and Ocu-Guard Supple (K983581) received a 510(k) decision of Substantially Equivalent on November 6, 1998, 24 days after the submission was received.
What is the product code of K983581?
The FDA product code is HQX – Implant, Orbital, Extra-Ocular, a Class II (moderate risk) device regulated under 21 CFR 886.3340.