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FDA 510(k)

PENTAX Medical Video Colonoscope EC34-i10T Series

K-Number: K180285 · 2018-10-26

ApplicantPentax Medical of America, Inc.
Decision Date2018-10-26
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Medical Video Colonoscope EC34-i10T Series is a medical device manufactured by Pentax Medical of America, Inc.. It received FDA 510(k) clearance on 2018-10-26 under approval number K180285. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX Medical Video Colonoscope EC34-i10T Series?

PENTAX Medical Video Colonoscope EC34-i10T Series is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Pentax Medical of America, Inc.. The 510(k) number is K180285.

When was PENTAX Medical Video Colonoscope EC34-i10T Series approved by the FDA?

PENTAX Medical Video Colonoscope EC34-i10T Series received FDA 510(k) clearance on 2018-10-26, under approval number K180285.

What company makes PENTAX Medical Video Colonoscope EC34-i10T Series?

PENTAX Medical Video Colonoscope EC34-i10T Series is manufactured by Pentax Medical of America, Inc..

What is the FDA product code for PENTAX Medical Video Colonoscope EC34-i10T Series?

The FDA product code for PENTAX Medical Video Colonoscope EC34-i10T Series is FDF.

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Related PubMed Literature

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Other Devices by Pentax Medical of America, Inc.

K180292PENTAX Video Upper G.I. Scope EG34-i10

Related Devices (Code: FDF)

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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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