Cleared Traditional

K131422 - PEERSCOPE SYSTEM

K131422 is the FDA 510(k) clearance for PEERSCOPE SYSTEM by Endochoice, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDS) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K131422 · Endochoice, Inc. · Gastroenterology & Urology device
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Oct 2013
Decision
147d
Days
Class 2
Risk

K131422 is an FDA 510(k) clearance for the PEERSCOPE SYSTEM. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Endochoice, Inc. (Caesarea, IL). The FDA issued a Cleared decision on October 10, 2013 after a review of 147 days - within the typical 510(k) review window.

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 Endochoice, Inc. devices

Submission Details

510(k) Number K131422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2013
Decision Date October 10, 2013
Days to Decision 147 days
Submission Type Traditional
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
17d slower than avg
Panel avg: 130d · This submission: 147d
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 64
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K131422.
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K153206 · Fujifilm Medical System U.S.A., Inc. · Mar 2016
Fuse Gastroscopy System
K152182 · Endochoice, Inc. · Dec 2015
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
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K120446 · Fujinon, Inc. · Aug 2012