Cleared Special

K172299 - Accordion Piccolo Stone Management Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172299 · Ths International, Inc. D/B/A Accordion Medical · Gastroenterology & Urology device
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Sep 2017
Decision
50d
Days
Class 2
Risk

K172299 is an FDA 510(k) clearance for the Accordion Piccolo Stone Management Device. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Ths International, Inc. D/B/A Accordion Medical (Indianapolis, US). The FDA issued a Cleared decision on September 19, 2017 after a review of 50 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ths International, Inc. D/B/A Accordion Medical devices

Submission Details

510(k) Number K172299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2017
Decision Date September 19, 2017
Days to Decision 50 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.