Cleared Traditional

K140295 - GIS ENDOSCOPIC OPTICAL LENS

K140295 is the FDA 510(k) clearance for GIS ENDOSCOPIC OPTICAL LENS by Gi Scientific, LLC. It is a Class 2 Gastroenterology & Urology device (product code FDS) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K140295 · Gi Scientific, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
168d
Days
Class 2
Risk

K140295 is an FDA 510(k) clearance for the GIS ENDOSCOPIC OPTICAL LENS. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Gi Scientific, LLC (Newbury, US). The FDA issued a Cleared decision on July 24, 2014 after a review of 168 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gi Scientific, LLC devices

Submission Details

510(k) Number K140295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2014
Decision Date July 24, 2014
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 130d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. 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 - FDS Gastroscope And Accessories, Flexible/rigid

All 57
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K140295.
FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
K162749 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2017
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K153206 · Fujifilm Medical System U.S.A., Inc. · Mar 2016
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
K142629 · Fujifilm Medical System U.S.A., Inc. · May 2015
FOREIGN BODY HOOD
K130148 · United States Endoscopy Group, Inc. · Aug 2013
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N
K123317 · Olympus Medical Systems Corporation · Dec 2012
KARL STORZ VIDEO GASTROSCOPES
K060907 · KARL STORZ Endoscopy-America, Inc. · Nov 2006