PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor
FDA 510(k) K181292 · Cogentix Medical, Inc.
510(k) numberK181292
Submission
- Device name
- PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor
- Applicant
- Cogentix Medical, Inc.
Orangeburg, NY, US - Received
- May 16, 2018
- Decision date
- November 15, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K181020 | Cytosponge Cell Collection DeviceEOX · Traditional | Covidien, LLC | 08/16/2018SE |
More from Covidien, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253905 | PrimeSight UltraView SystemFAJ · Traditional | 04/07/2026SE |
Questions and answers
When was PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor cleared by the FDA?
PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor (K181292) received a 510(k) decision of Substantially Equivalent on November 15, 2018, 183 days after the submission was received.
What is the product code of K181292?
The FDA product code is EOX – Esophagoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4710.