Cleared Traditional

ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510

K102887 · Percutaneous Systems, Inc. · Gastroenterology & Urology
May 2011
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K102887 is an FDA 510(k) clearance for the ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510, a Dislodger, Stone, Basket, Ureteral, Metal (Class II — Special Controls, product code FFL), submitted by Percutaneous Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 16, 2011, 228 days after receiving the submission on September 30, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.

Submission Details

510(k) Number K102887 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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