Cleared Traditional

EndoRotor (K170120) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170120 · Interscope, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
95d
Days
Class 2
Risk

K170120 is an FDA 510(k) clearance for the EndoRotor. Classified as Endoscopic Morcellator Gastroenterology (product code PTE), Class II - Special Controls.

Submitted by Interscope, Inc. (Worchester, US). The FDA issued a Cleared decision on April 18, 2017 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1690 - 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 Interscope, Inc. devices

Submission Details

510(k) Number K170120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2017
Decision Date April 18, 2017
Days to Decision 95 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
35d faster than avg
Panel avg: 130d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PTE Endoscopic Morcellator Gastroenterology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
Definition For Use In Endoscopic Procedures By A Trained Gastroenterologist To Resect And Remove Residual Tissue From The Peripheral Margins Following Emr (endoscopic Mucosal Resection)
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.