Cleared Special

K172299 - Accordion Piccolo Stone Management Device

K172299 is an FDA 510(k) clearance for Accordion Piccolo Stone Management Device, manufactured by Ths International, Inc. D/B/A Accordion Medical. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Special 510(k) pathway after a 50-day FDA review.

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

FDA 510(k) Submission Details - K172299

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.

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 K172299.
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