Cleared Traditional

K052048 - ACCORDION

K052048 is an FDA 510(k) clearance for ACCORDION, manufactured by Percutaneous Systems, Incorporated. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K052048 · Percutaneous Systems, Incorporated · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
46d
Days
Class 2
Risk

K052048 is an FDA 510(k) clearance for the ACCORDION. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Percutaneous Systems, Incorporated (Mountain View, US). The FDA issued a Cleared decision on September 13, 2005 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4680 - 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 Percutaneous Systems, Incorporated devices

FDA 510(k) Submission Details - K052048

510(k) Number K052048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2005
Decision Date September 13, 2005
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFL Device Classification - Class 2, Special Controls

Product Code FFL Dislodger, Stone, Basket, Ureteral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4680
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 - FFL Dislodger, Stone, Basket, Ureteral, Metal

All 27
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K052048.
Peralta Stone Removal Catheter
K190492 · Calcula Technologies, Inc. · Jul 2019
REPROCESSED STONE RETRIEVAL BASKETS
K012581 · Sterilmed, Inc. · Feb 2002
AMS FOREIGN BODY EXTRATOR
K972091 · American Medical Systems, Inc. · Aug 1997
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
K962387 · Olympus America, Inc. · Jul 1996
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS
K961248 · C.R. Bard, Inc. · May 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS
K955049 · Olympus America, Inc. · Dec 1995