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FDA 510(k)

PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope

K-Number: K173554 · 2018-01-19

ApplicantPentax of America, Inc.
Decision Date2018-01-19
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2018-01-19 under approval number K173554. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope?

PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Pentax of America, Inc.. The 510(k) number is K173554.

When was PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope approved by the FDA?

PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope received FDA 510(k) clearance on 2018-01-19, under approval number K173554.

What company makes PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope?

PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope?

The FDA product code for PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope is EOQ.

Related Clinical Trials

NCT07300878 Effect of Video Laryngoscopy Versus Conventional Laryngoscopy Upon Hemodynamics COMPLETED 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 NCT05967507 Laryngoscopy for Neonatal and Infant Airway Management wIth Supplemental Oxygen at Different Flow Rates (OPTIMISE-2) 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

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 K190805PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL

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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.

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