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PENTAX Video Colonoscopes (EC Family)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181084

by PENTAX of America, Inc.

Identifiers

510(k) Number
K181084 FDA 510(k)
FDA Product Code
FDF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

PENTAX Video Colonoscopes (EC Family) are flexible endoscopes used for visualization and surgical intervention in the lower digestive tract. The device consists of an insertion portion with distal end, bending section, objective lens, light guide, and instrument channel, and a control body with angulation levers, suction controls, and remote functions.

The device is supplied by Pentax of America, Inc. and has received FDA 510(k) clearance under K181084. It is classified as a Class II medical device under regulation number 876.1500 and product code FDF, with authorization for gastroenterology and urology use.

Frequently asked questions

What is the PENTAX Video Colonoscope (EC Family) used for?

The PENTAX Video Colonoscopes (EC Family) are flexible endoscopes designed for visualization and surgical intervention in the lower digestive tract, including the colon and rectum, enabling diagnostic and therapeutic gastroenterology and urology procedures as indicated in its FDA 510(k) submission.

How is the PENTAX Video Colonoscope (EC Family) supplied and what is its sterility status?

The device is supplied by Pentax of America, Inc. as a reusable endoscope requiring reprocessing between uses; it is not supplied sterile and must be cleaned and high-level disinfected or sterilized according to manufacturer instructions and institutional protocols before each patient use.

What regulatory clearance does the PENTAX Video Colonoscope (EC Family) have and under which number?

The PENTAX Video Colonoscopes (EC Family) received FDA 510(k) clearance under submission number K181084, classified as a Class II medical device under regulation 876.1500 with product code FDF, confirming substantial equivalence to a legally marketed predicate device for gastroenterology and urology use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PENTAX Video Colonoscopes (EC Family) (K181084) - Innolitics, K181084 FDA 510(k) - PENTAX Video Colonoscopes (EC Family), PENTAX GI/Colonoscopes (K251256) | Medical Device Navigator, PDF PENTAX of America, Inc Gurvinder Singh Nanda 3 Paragon Dr Montvale, New ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
PENTAX of America, Inc.

Sources (1)

  • FDA 510(k) K181084 24 fields · synced Sep 25, 2026