Electronic Unit
FDA 510(k) K832887 · Surgi-Quip Inc.U
510(k) numberK832887
Submission
- Device name
- Electronic Unit
- Applicant
- Surgi-Quip Inc.U
Mchenry, IL, US - Received
- August 26, 1983
- Decision date
- October 4, 1983
- 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 |
| 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 |
|---|---|---|
| K841116 | Mobile Ophthalmic Operating TableFWX · Traditional | 05/09/1984SE |
| K841115 | Charles/Mcintyre Giant Break TableFQO · Traditional | 05/09/1984SE |
| K840004 | Wee Bag O'MercuryLCC · Traditional | 03/22/1984SE |
| K822554 | Cement Extraction Instrumentation · Traditional | 09/14/1982SE |
| K822427 | Self-Contained Mobile Ophthal. Oper. .FSE · Traditional | 09/14/1982SE |
| K822428 | Surgi-Quip Microscope StandHBN · Traditional | 09/02/1982SE |
| K822426 | Mcintyre Microscope StandHBN · Traditional | 09/02/1982SE |
Questions and answers
When was Electronic Unit cleared by the FDA?
Electronic Unit (K832887) received a 510(k) decision of Substantially Equivalent on October 4, 1983, 39 days after the submission was received.
What is the product code of K832887?
The FDA product code is EPT – Microscope, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4700.