M. E. R. Surgical Co. Omin Instrument System
FDA 510(k) K951424 · M.E.R. Surgical Co.
510(k) numberK951424
Submission
- Device name
- M. E. R. Surgical Co. Omin Instrument System
- Applicant
- M.E.R. Surgical Co.
Walnut, CA, US - Received
- March 27, 1995
- Decision date
- May 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EOX – Esophagoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4710
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code EOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233142 | EndoSign® Cell collection device (ES-CYT-102)EOX · Traditional | Cyted Limited | 01/19/2024SE |
| K230339 | EsoCheck Cell Collection DeviceEOX · Special | Lucid Diagnostics, Inc. | 02/24/2023SESK |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10EOX · Traditional | Pentax of America, Inc. | 12/02/2022SE |
| K222366 | EsoCheck Cell Collection DeviceEOX · Traditional | Lucid Diagnostics, Inc. | 10/26/2022SESK |
| K203450 | EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)EOX · Traditional | Capnostics, LLC | 05/04/2021SE |
| K210137 | EsoCheck Cell Collection DeviceEOX · Special | Lucid Diagnostics, Inc. | 02/18/2021SESK |
| K192523 | CMOS Video Esophagoscope SSUEOX · Traditional | Karl Storz SE & CO. KG | 01/24/2020SE |
| K183262 | EsoCheck CCD Cell Collection DeviceEOX · Traditional | Lucid Diagnostics, Inc. | 06/21/2019SESK |
| K182159 | Strome-Blitzer Cytology BalloonEOX · Traditional | Adn International, LLC | 06/13/2019SE |
| K181292 | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video ProcessorEOX · Traditional | Cogentix Medical, Inc. | 11/15/2018SE |
More from Cogentix Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944309 | M.E.R. Surgical Co. Omni Instrument SystemGCJ · Traditional | 04/03/1995SE |
Questions and answers
When was M. E. R. Surgical Co. Omin Instrument System cleared by the FDA?
M. E. R. Surgical Co. Omin Instrument System (K951424) received a 510(k) decision of Substantially Equivalent on May 9, 1995, 43 days after the submission was received.
What is the product code of K951424?
The FDA product code is EOX – Esophagoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4710.