Cleared Traditional

K102887 - ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510

K102887 is an FDA 510(k) clearance for ACCORDION STONE MANAGEMENT DEVICE MODEL..., manufactured by Percutaneous Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFL cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K102887 · Percutaneous Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
228d
Days
Class 2
Risk

K102887 is an FDA 510(k) clearance for the ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510. Classified as Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), Class II - Special Controls.

Submitted by Percutaneous Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 16, 2011 after a review of 228 days - an extended review 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: 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, Inc. devices

FDA 510(k) Submission Details - K102887

510(k) Number K102887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date May 16, 2011
Days to Decision 228 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
97d slower than avg
Panel avg: 131d · This submission: 228d
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 43
Devices cleared under the same product code (FFL) and FDA review panel - the closest regulatory comparables to K102887.
Peralta Stone Removal Catheter
K190492 · Calcula Technologies, Inc. · Jul 2019
Accordion Piccolo Stone Management Device
K172299 · Ths International, Inc. D/B/A Accordion Medical · Sep 2017
COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015
K082803 · Percutaneous Systems, Inc. · Nov 2008
ACCORDION
K052048 · Percutaneous Systems, Incorporated · Sep 2005
REPROCESSED STONE RETRIEVAL BASKETS
K012581 · Sterilmed, Inc. · Feb 2002
AMS FOREIGN BODY EXTRATOR
K972091 · American Medical Systems, Inc. · Aug 1997