Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PENTAX Medical Video Esophagoscope EE17-J10

K-Number: K223072 · 2022-12-02

ApplicantPentax of America, Inc.
Decision Date2022-12-02
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Video Esophagoscope EE17-J10 is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2022-12-02 under approval number K223072. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical Video Esophagoscope EE17-J10?

PENTAX Medical Video Esophagoscope EE17-J10 is a medical device that received FDA 510(k) clearance on 2022-12-02. It is manufactured by Pentax of America, Inc.. The 510(k) number is K223072.

When was PENTAX Medical Video Esophagoscope EE17-J10 approved by the FDA?

PENTAX Medical Video Esophagoscope EE17-J10 received FDA 510(k) clearance on 2022-12-02, under approval number K223072.

What company makes PENTAX Medical Video Esophagoscope EE17-J10?

PENTAX Medical Video Esophagoscope EE17-J10 is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical Video Esophagoscope EE17-J10?

The FDA product code for PENTAX Medical Video Esophagoscope EE17-J10 is EOX.

Related Clinical Trials

NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT05457166 Use of the KASPARD System for Fall Prevention in Nursing Homes COMPLETED NCT07530731 Platforms Comparison Study - NIXOS-COMPARISON ENROLLING_BY_INVITATION NCT07568093 PARO-agitation-study RECRUITING NCT07280065 REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool RECRUITING NCT06473558 Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Pentax of America, Inc.

K162151PENTAX Medical ENT Video Imaging System K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner K182004PENTAX Medical Endoscopic Ultrasound System K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope K173679PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

View all 39 devices →

Related Devices (Code: EOX)

K152794Cytosponge Cell Collection DeviceCovidien, LLC K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc. K181020Cytosponge Cell Collection DeviceCovidien, LLC K183262EsoCheck CCD Cell Collection DeviceLucid Diagnostics, Inc. K182159Strome-Blitzer Cytology BalloonAdn International, LLC K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑