Prizm Keratome Blade, Model MK8512M2
FDA 510(k) K033236 · Surgin Surgical Instrumentation, Inc.
510(k) numberK033236
Submission
- Device name
- Prizm Keratome Blade, Model MK8512M2
- Applicant
- Surgin Surgical Instrumentation, Inc.
Tustin, CA, US - Received
- October 6, 2003
- Decision date
- March 26, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HNO – Keratome, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
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| K082043 | Carriazo-Pendular MicrokeratomeHNO · Traditional | Schwind Eye-Tech-Solutions GmbH & Co. KG | 08/01/2008SE |
| K062465 | Zyoptix XP Epi Separator SystemHNO · Traditional | Bausch & Lomb, Inc. | 09/06/2006SE |
| K052891 | Horizon Epikeratome Disposable Microkeratome SystemHNO · Traditional | Hawken Industries | 03/23/2006SE |
| K051486 | Norwood Abbey Centurion Ses EpikeratomeHNO · Special | Norwood Abbey , Ltd. | 07/06/2005SE |
| K043183 | Epi-KHNO · Traditional | Moria SA | 03/25/2005SE |
| K043150 | Amadeus II EpikeratomeHNO · Special | Sis Ltd., Surgical Instrument Systems | 01/31/2005SE |
| K042083 | Modification to Visitome 20-10 MicrokeratomeHNO · Traditional | Biovision AG | 11/16/2004SE |
More from Biovision AG
| 510(k) | Device | Decision |
|---|---|---|
| K082110 | Dual Syringe HolderFMG · Traditional | 06/17/2009SE |
| K033182 | Prizm Keratome Blade (B.D. Model), Model MK8530BDHNO · Traditional | 01/30/2004SE |
| K011195 | Prizm Blade (Moria Model) LSK / MK8510LSK; Prizm Blade (Moria Model) CB / MK8511CBHNO · Traditional | 11/06/2001SE |
| K994015 | Accublade (Acs Model), MK8507, Accublade (Hansotome Model), MK8508HNO · Traditional | 03/15/2000SE |
| K980849 | Surgin KitMSR · Traditional | 07/09/1998SE |
| K954238 | Surgin Genisis HandpieceHQC · Traditional | 12/08/1995SE |
| K950600 | Vacuum Surge SupresserHQC · Traditional | 05/10/1995SE |
| K942945 | Cassette System for StorzHQC · Traditional | 12/05/1994SE |
| K942944 | Irrigation/Bipolar SetGEI · Traditional | 09/27/1994SE |
| K942897 | Opthalmic WipeHQZ · Traditional | 08/05/1994SE |
Questions and answers
When was Prizm Keratome Blade, Model MK8512M2 cleared by the FDA?
Prizm Keratome Blade, Model MK8512M2 (K033236) received a 510(k) decision of Substantially Equivalent on March 26, 2004, 172 days after the submission was received.
What is the product code of K033236?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.