Cleared Traditional

K161791 - Aer-O-Scope Colonoscope System

K161791 is an FDA 510(k) clearance for Aer-O-Scope Colonoscope System, manufactured by Gi View , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDF cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K161791 · Gi View , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
43d
Days
Class 2
Risk

K161791 is an FDA 510(k) clearance for the Aer-O-Scope Colonoscope System. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Gi View , Ltd. (Ramat Gan, IL). The FDA issued a Cleared decision on August 11, 2016 after a review of 43 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gi View , Ltd. devices

FDA 510(k) Submission Details - K161791

510(k) Number K161791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2016
Decision Date August 11, 2016
Days to Decision 43 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 73
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K161791.
invendoscopy E210 System
K173085 · Invendo Medical GmbH · Jan 2018
Oracle EUS Balloon
K163492 · United States Endoscopy Group, Inc. · Jan 2017
Fujifilm Endoscope Models EC-600HL and EC-600LS
K162622 · Fujifilm Medical Systems U.S.A, Inc. · Oct 2016
Fujifilm Video Colonoscope Model EC-600WL V2
K160196 · Fujifilm Medical Systems U.S.A, Inc. · Feb 2016
Balloon controller PB-30
K153483 · Fujifilm Medical Systems U.S.A, Inc. · Dec 2015
FUJIFILM Endoscope Models EC-600HL and EC-600LS
K143732 · Fujifilm Medical Systems U.S.A, Inc. · Jul 2015