Storz/Olympus Microscope System
FDA 510(k) K812234 · Storz Instrument Co.
510(k) numberK812234
Submission
- Device name
- Storz/Olympus Microscope System
- Applicant
- Storz Instrument Co.
Mchenry, IL, US - Received
- August 11, 1981
- Decision date
- September 11, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EPT – Microscope, Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4700
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code EPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942233 | MKM (Multiple Coordinate Manipulator) SystemEPT · Traditional | Carl Zeiss, Inc. | 07/01/1994SE |
| K931284 | Microdyne Office Surgical MicroscopeEPT · Traditional | Microdyne, Inc. | 11/18/1993SE |
| K933310 | Micrins Contrast Background MaterialEPT · Traditional | Micrins Surgical, Inc. | 08/19/1993SE |
| K903412 | Storz Model M705 And/Or M706 Ceiling Mounted Micr.EPT · Traditional | Storz Instrument Co. | 09/20/1990SE |
| K883581 | Opmi CSEPT · Traditional | Carl Zeiss, Inc. | 09/13/1988SE |
| K882269 | Storz Diagnostic Microscope SystemEPT · Traditional | Storz Instrument Co. | 06/23/1988SE |
| K860811 | Zeiss Voice Control System for Opmi'sEPT · Traditional | Carl Zeiss, Inc. | 04/30/1986SE |
| K844858 | Storz/Urban Surgical Microscope SystemEPT · Traditional | Storz Instrument Co. | 03/25/1985SE |
| K832887 | Electronic UnitEPT · Traditional | Surgi-Quip Inc.U | 10/04/1983SE |
| K823011 | VC IIIEPT · Traditional | Teknar, Inc. | 11/08/1982SE |
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| K972664 | Storz Millennium Viscous Fluid SystemMRH · Traditional | 10/10/1997SE |
| K971439 | Storz Microflow and Storz Standard Phacoemulsification NeedlesHQC · Traditional | 06/17/1997SE |
| K964743 | Storz E8010 Ergotec/Premiere AdaptorHQE · Traditional | 02/03/1997SE |
| K960024 | Storz D7120 Phaco Handpiece Maintenance Kit & Storz D7125 Phaco Handpiece Needle WrenchHQC · Traditional | 09/20/1996SE |
| K960061 | Storz D7108 Microscissors Handpiece/Storz D7106 Microscissors Drive TubeHQE · Traditional | 09/18/1996SE |
| K960003 | Storz D7116 Microvit Vitrectomy Cutter ExtensionHQC · Traditional | 08/29/1996SE |
| K962131 | Storz D4600 Air Exchange Line PackHQC · Traditional | 08/23/1996SE |
| K961874 | Storz DP5100 Anterior Collection Cassette PackHQC · Traditional | 08/06/1996SE |
Questions and answers
When was Storz/Olympus Microscope System cleared by the FDA?
Storz/Olympus Microscope System (K812234) received a 510(k) decision of Substantially Equivalent on September 11, 1981, 31 days after the submission was received.
What is the product code of K812234?
The FDA product code is EPT – Microscope, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4700.