Microscope
FDA 510(k) K822561 · Treace Medical, Inc.
510(k) numberK822561
Submission
- Device name
- Microscope
- Applicant
- Treace Medical, Inc.
Mchenry, IL, US - Received
- August 24, 1982
- Decision date
- September 14, 1982
- 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 |
More from Teknar, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883727 | Bucket Prosthesis PorpETB · Traditional | 01/13/1989SE |
| K882349 | Mallet, SurgicalHXL · Traditional | 06/23/1988SE |
| K874779 | Bipolator 50GEI · Traditional | 01/29/1988SE |
| K873154 | Treace Magnum Oto-Tool SystemERL · Traditional | 09/04/1987SE |
| K872000 | Eye GardHOY · Traditional | 07/21/1987SE |
| K870765 | Cannulated Instrument CleanersEKW · Traditional | 05/27/1987SE |
| K871706 | Optha PrepHMT · Traditional | 05/18/1987SE |
| K870759 | Cleaning Solution, Catalog No. 8203LRJ · Traditional | 05/07/1987SE |
| K870766 | Prosthesis WireETB · Traditional | 04/15/1987SE |
| K870764 | Schuknecht Wire Cutting Scissors · Traditional | 03/18/1987SE |
Questions and answers
When was Microscope cleared by the FDA?
Microscope (K822561) received a 510(k) decision of Substantially Equivalent on September 14, 1982, 21 days after the submission was received.
What is the product code of K822561?
The FDA product code is EPT – Microscope, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4700.