Cleared Traditional

K061324 - EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRI...

K061324 is an FDA 510(k) clearance for EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRI..., manufactured by Rtc Inc.-Memcath Technologies, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K061324 · Rtc Inc.-Memcath Technologies, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
40d
Days
Class 2
Risk

K061324 is an FDA 510(k) clearance for the EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Rtc Inc.-Memcath Technologies, LLC (West St. Paul, US). The FDA issued a Cleared decision on June 20, 2006 after a review of 40 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 Rtc Inc.-Memcath Technologies, LLC devices

FDA 510(k) Submission Details - K061324

510(k) Number K061324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2006
Decision Date June 20, 2006
Days to Decision 40 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
90d faster than avg
Panel avg: 130d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FED Device Classification - Class 2, Special Controls

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.
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 - FED Endoscopic Access Overtube, Gastroenterology-urology

All 67
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K061324.
ENTEROSCOPY OVERTUBE, MODEL 00712140
K100081 · United States Endoscopy Group, Inc. · Apr 2010
COLONIC SPLINTING OVERTUBE, MODEL 00711145
K092221 · United States Endoscopy Group, Inc. · Oct 2009
FUJINON STERILE OVERTUBES
K091773 · Fujinon, Inc. · Aug 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · Boston Scientific Corp · Jun 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K043418 · Cook Urological, Inc. · Mar 2005
DISPOSABLE OVERTUBE
K040836 · United States Endoscopy Group, Inc. · Jun 2004