Cleared Traditional

K140295 - GIS ENDOSCOPIC OPTICAL LENS

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

K140295 · Gi Scientific, LLC · Gastroenterology & Urology device
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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

FDA 510(k) Submission Details - K140295

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 131d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDS Device Classification - Class 2, Special Controls

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 75
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K140295.
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PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)
K131902 · Pentax Medical Company · Apr 2014
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K131422 · Endochoice, Inc. · Oct 2013
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K130148 · United States Endoscopy Group, Inc. · Aug 2013