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FDA 510(k)

PENTAX Video Colonoscopes (EC Family)

K-Number: K181084 · 2019-01-18

ApplicantPentax of America, Inc.
Decision Date2019-01-18
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX Video Colonoscopes (EC Family) is a medical device manufactured by Pentax of America, Inc.. It received FDA 510(k) clearance on 2019-01-18 under approval number K181084. 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 Video Colonoscopes (EC Family)?

PENTAX Video Colonoscopes (EC Family) is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Pentax of America, Inc.. The 510(k) number is K181084.

When was PENTAX Video Colonoscopes (EC Family) approved by the FDA?

PENTAX Video Colonoscopes (EC Family) received FDA 510(k) clearance on 2019-01-18, under approval number K181084.

What company makes PENTAX Video Colonoscopes (EC Family)?

PENTAX Video Colonoscopes (EC Family) is manufactured by Pentax of America, Inc..

What is the FDA product code for PENTAX Video Colonoscopes (EC Family)?

The FDA product code for PENTAX Video Colonoscopes (EC Family) is FDF.

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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

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Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.

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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