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FDA 510(k)

PENTAX Medical EPK-3000 Video Imaging System

K-Number: K172156 · 2018-04-05

ApplicantPentax Medical
Decision Date2018-04-05
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical EPK-3000 Video Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Medical. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K172156. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical EPK-3000 Video Imaging System?

PENTAX Medical EPK-3000 Video Imaging System is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Pentax Medical. The 510(k) number is K172156.

When did PENTAX Medical EPK-3000 Video Imaging System receive FDA 510(k) clearance?

PENTAX Medical EPK-3000 Video Imaging System received FDA 510(k) clearance on 2018-04-05, under 510(k) number K172156.

Who is the listed applicant for PENTAX Medical EPK-3000 Video Imaging System?

The FDA 510(k) record lists Pentax Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENTAX Medical EPK-3000 Video Imaging System?

The FDA product code for PENTAX Medical EPK-3000 Video Imaging System is EOB.

Other records listing Pentax Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192280PENTAX Medical ED-3490TK Video DuodenoscopeK171011PENTAX Medical VIVIDEO ENT Videoscope SolutionK161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopeK163614PENTAX Medical ED34-i10T, Video Duodenoscope

Related Devices (Code: EOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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