Cleared Traditional

K090485 - COAXIAL ACCORDION ERCP DEVICE

K090485 is an FDA 510(k) clearance for COAXIAL ACCORDION ERCP DEVICE, manufactured by Percutaneous Systems, Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code LQR cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K090485 · Percutaneous Systems, Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
147d
Days
Class 2
Risk

K090485 is an FDA 510(k) clearance for the COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003. Classified as Dislodger, Stone, Biliary (product code LQR), Class II - Special Controls.

Submitted by Percutaneous Systems, Incorporated (Palo Alto, US). The FDA issued a Cleared decision on July 22, 2009 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 876.5010 - 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 Percutaneous Systems, Incorporated devices

FDA 510(k) Submission Details - K090485

510(k) Number K090485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2009
Decision Date July 22, 2009
Days to Decision 147 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
17d slower than avg
Panel avg: 130d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LQR Device Classification - Class 2, Special Controls

Product Code LQR Dislodger, Stone, Biliary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 - LQR Dislodger, Stone, Biliary

All 26
Devices cleared under the same product code (LQR) and FDA review panel - the closest regulatory comparables to K090485.
Single Use Retrieval Nitinol Basket V
K170811 · Olympus Medical Systems Corp. · Nov 2017
NCompass Nitinol Stone Extractors
K173009 · Cook Incorporated · Nov 2017
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
K091495 · Olympus Medical Systems Corporation · Sep 2009
SPYCATCH STONE RETRIEVAL BASKET
K071066 · Boston Scientific Corp · Jun 2007
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
K952149 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
ENDOSCOPIC BILIARY CATHETER
K946358 · Boston Scientific Corp · Apr 1995