Micrins Contrast Background Material
FDA 510(k) K933310 · Micrins Surgical, Inc.
510(k) numberK933310
Submission
- Device name
- Micrins Contrast Background Material
- Applicant
- Micrins Surgical, Inc.
Lake Forest, IL, US - Received
- July 7, 1993
- Decision date
- August 19, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K822561 | MicroscopeEPT · Traditional | Treace Medical, Inc. | 09/14/1982SE |
More from Treace Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993970 | Micrins Microsurgical SutureGAR · Traditional | 03/30/2000SE |
| K982278 | Micrins Micro Anastomosis ClampDXC · Traditional | 03/26/1999SE |
| K872989 | Micrins Needle HolderHXK · Traditional | 08/21/1987SE |
| K872991 | Micrins Forceps 2010GEN · Traditional | 08/17/1987SE |
| K872990 | Micrins Surgical ScissorFZT · Traditional | 08/17/1987SE |
Questions and answers
When was Micrins Contrast Background Material cleared by the FDA?
Micrins Contrast Background Material (K933310) received a 510(k) decision of Substantially Equivalent on August 19, 1993, 43 days after the submission was received.
What is the product code of K933310?
The FDA product code is EPT – Microscope, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4700.