Opmi CS
FDA 510(k) K883581 · Carl Zeiss, Inc.
510(k) numberK883581
Submission
- Device name
- Opmi CS
- Applicant
- Carl Zeiss, Inc.
Thornwood, NY, US - Received
- August 22, 1988
- Decision date
- September 13, 1988
- 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 |
| 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 |
| K822561 | MicroscopeEPT · Traditional | Treace Medical, Inc. | 09/14/1982SE |
More from Treace Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K013402 | Visulas 532SGEX · Special | 11/14/2001SE |
| K003885 | Visulas Yag IIGEX · Traditional | 02/22/2001SE |
| K993357 | IolmasterHJO · Traditional | 03/20/2000SE |
| K983868 | Opmi Twiner Surgical MicroscopeGEX · Traditional | 01/29/1999SE |
| K965139 | Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) SystemHAW · Traditional | 04/23/1997SE |
| K961380 | CPC ProbeGEX · Traditional | 03/17/1997SE |
| K961171 | Humphrey Oct ScannerHLI · Traditional | 06/21/1996SE |
| K954167 | Humphrey Field Analyzer (Hfa II)HPT · Traditional | 11/24/1995SE |
| K952894 | Visulink 900 ArgonHQF · Traditional | 08/14/1995SE |
| K950985 | Zeiss Endolive Stero EndoscopeGCJ · Traditional | 03/29/1995SE |
Questions and answers
When was Opmi CS cleared by the FDA?
Opmi CS (K883581) received a 510(k) decision of Substantially Equivalent on September 13, 1988, 22 days after the submission was received.
What is the product code of K883581?
The FDA product code is EPT – Microscope, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4700.