Mcintyre Surgical Goniolens
FDA 510(k) K890977 · Ocular Instruments, Inc.
510(k) numberK890977
Submission
- Device name
- Mcintyre Surgical Goniolens
- Applicant
- Ocular Instruments, Inc.
Bellevue, WA, US - Received
- February 27, 1989
- Decision date
- May 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKS – Prism, Gonioscopic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1660
- Specialty
- Ophthalmic
Other 510(k)s with product code HKS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140368 | Family of Disposable LensesHKS · Traditional | Sensor Medical Technology, LLC | 04/29/2014SE |
| K935302 | Osher Surgical Gonio/Posterior Pole LensHKS · Traditional | Ocular Instruments, Inc. | 04/01/1994SE |
| K895846 | Two Mirror Gonio LensHKS · Traditional | Ocular Instruments, Inc. | 12/18/1989SE |
| K862713 | Abraham Iridectomy Lens (Yag Laser)HKS · Traditional | Ocular Instruments, Inc. | 08/21/1986SE |
| K862692 | Karickhoff Diagnostic/Laser LensHKS · Traditional | Ocular Instruments, Inc. | 08/21/1986SE |
| K862512 | Ritch Trabeculoplasty Laser LensHKS · Traditional | Ocular Instruments, Inc. | 07/11/1986SE |
| K862024 | Sussman Four Mirror Hand Held GonioprismHKS · Traditional | Ocular Instruments, Inc. | 07/11/1986SE |
| K861027 | Keta Hand-Held TonometerHKS · Traditional | Keta Corp. | 05/06/1986SE |
| K830169 | Dorc Adjustable Image ContactsHKS · Traditional | Jedmed Instrument Co. | 02/07/1983SE |
More from Jedmed Instrument Co.
| 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 Mcintyre Surgical Goniolens cleared by the FDA?
Mcintyre Surgical Goniolens (K890977) received a 510(k) decision of Substantially Equivalent on May 23, 1989, 85 days after the submission was received.
What is the product code of K890977?
The FDA product code is HKS – Prism, Gonioscopic, a Class I (low risk) device regulated under 21 CFR 886.1660.