Cleared Special

K162622 - Fujifilm Endoscope Models EC-600HL and EC-600LS

K162622 is an FDA 510(k) clearance for Fujifilm Endoscope Models EC-600HL and ..., manufactured by Fujifilm Medical Systems U.S.A, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Special 510(k) pathway after a 28-day FDA review.

K162622 · Fujifilm Medical Systems U.S.A, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 2016
Decision
28d
Days
Class 2
Risk

K162622 is an FDA 510(k) clearance for the Fujifilm Endoscope Models EC-600HL and EC-600LS. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Wayne, US). The FDA issued a Cleared decision on October 18, 2016 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fujifilm Medical Systems U.S.A, Inc. devices

FDA 510(k) Submission Details - K162622

510(k) Number K162622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2016
Decision Date October 18, 2016
Days to Decision 28 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FDF Device Classification - Class 2, Special Controls

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDF Colonoscope And Accessories, Flexible/rigid

All 95
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K162622.
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