Cleared Traditional

K052084 - ENDO-EASE ENDOSCOPIC OVERTUBE

K052084 is an FDA 510(k) clearance for ENDO-EASE ENDOSCOPIC OVERTUBE, manufactured by Spirus Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K052084 · Spirus Medical, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2005
Decision
43d
Days
Class 2
Risk

K052084 is an FDA 510(k) clearance for the ENDO-EASE ENDOSCOPIC OVERTUBE. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Spirus Medical, Inc. (Ayer, US). The FDA issued a Cleared decision on September 14, 2005 after a review of 43 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 Spirus Medical, Inc. devices

FDA 510(k) Submission Details - K052084

510(k) Number K052084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2005
Decision Date September 14, 2005
Days to Decision 43 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
88d faster than avg
Panel avg: 131d · This submission: 43d
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 92
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K052084.
MODIFICATION TO ENDO-EASE
K062805 · Spirus Medical, Inc. · Oct 2006
EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
K061324 · Rtc Inc.-Memcath Technologies, LLC · Jun 2006
USGI TRANSPORT ENDOSCOPIC GUIDE
K061216 · Usgi Medical · May 2006
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
K051919 · Usgi Medical · Jul 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · Boston Scientific Corp · Jun 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K043418 · Cook Urological, Inc. · Mar 2005