Landers Notched Irrigating Vitrectomy Lens Ring
FDA 510(k) K912269 · Ocular Instruments, Inc.
510(k) numberK912269
Submission
- Device name
- Landers Notched Irrigating Vitrectomy Lens Ring
- Applicant
- Ocular Instruments, Inc.
Bellevue, WA, US - Received
- May 22, 1991
- Decision date
- August 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HNH – Ring, Ophthalmic (Flieringa)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912268 | Landers Notched Vitrectomy Lens RingHNH · Traditional | Ocular Instruments, Inc. | 08/07/1991SE |
| K912151 | Landers Three Strut Vitrectomy Lens RingHNH · Traditional | Ocular Instruments, Inc. | 07/25/1991SE |
| K902496 | Landers Vitrectomy Lens Ring W/InfusionHNH · Traditional | Ocular Instruments, Inc. | 07/24/1990SE |
| K863775 | RK Vacuum Fixation Ring SystemHNH · Traditional | Ameritek, Inc. | 10/20/1986SE |
| K850991 | Landers Vitrectomy Lens Ring SystemsHNH · Traditional | Ocular Instruments, Inc. | 03/29/1985SE |
| K832912 | Gelender Vacuum Fixation Ring SysHNH · Traditional | Miami Eye Technology, Inc. | 01/10/1984SE |
More from Miami Eye Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K014170 | Staurenghi Wide Field Scanning Laser LensHJK · Traditional | 03/04/2002SE |
| K012096 | Disposable Vitrectomy LensHJK · Traditional | 08/24/2001SE |
| K933976 | Mandelkorn Suture Lysis LensHJK · Traditional | 11/08/1994SE |
| K933264 | Ritch Nylon Suture Laser LensHJK · Traditional | 10/31/1994SE |
| K941420 | 50 Degree Hri Prism LensHJK · Traditional | 08/29/1994SE |
| K935302 | Osher Surgical Gonio/Posterior Pole LensHKS · Traditional | 04/01/1994SE |
| K923670 | Byrne Expulsive LensHJI · Traditional | 11/16/1992SE |
| K921414 | Trokel /3 Gonio Laser LensLQJ · Traditional | 11/16/1992SE |
| K914051 | Pediatric Vitrectomy Lens SetHJK · Traditional | 12/09/1991SE |
| K914117 | Landers High Refractive Index Vitrectomy Lens SetHJK · Traditional | 11/13/1991SE |
Questions and answers
When was Landers Notched Irrigating Vitrectomy Lens Ring cleared by the FDA?
Landers Notched Irrigating Vitrectomy Lens Ring (K912269) received a 510(k) decision of Substantially Equivalent on August 7, 1991, 77 days after the submission was received.
What is the product code of K912269?
The FDA product code is HNH – Ring, Ophthalmic (Flieringa), a Class I (low risk) device regulated under 21 CFR 886.4350.