PENTAX Medical Video Esophagoscope EE17-J10
FDA 510(k) K223072 · Pentax of America, Inc.
510(k) numberK223072
Submission
- Device name
- PENTAX Medical Video Esophagoscope EE17-J10
- Applicant
- Pentax of America, Inc.
Montvale, NJ, US - Received
- September 30, 2022
- Decision date
- December 2, 2022
- 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 |
| 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 |
| K181020 | Cytosponge Cell Collection DeviceEOX · Traditional | Covidien, LLC | 08/16/2018SE |
More from Covidien, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | 12/16/2025SE |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c)PEA · Traditional | 06/03/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | 01/03/2025SE |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…FDS · Traditional | 12/06/2024SE |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…FDT · Traditional | 08/01/2024SE |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH · Traditional | 07/24/2024SE |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10…EOQ · Traditional | 01/18/2024SE |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video…EOQ · Traditional | 01/12/2024SE |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14ODC · Traditional | 12/01/2023SE |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | 07/28/2023SE |
Questions and answers
When was PENTAX Medical Video Esophagoscope EE17-J10 cleared by the FDA?
PENTAX Medical Video Esophagoscope EE17-J10 (K223072) received a 510(k) decision of Substantially Equivalent on December 2, 2022, 63 days after the submission was received.
What is the product code of K223072?
The FDA product code is EOX – Esophagoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4710.