Cleared Traditional

COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015

K082803 · Percutaneous Systems, Inc. · Gastroenterology & Urology
Nov 2008
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K082803 is an FDA 510(k) clearance for the COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015, 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 November 13, 2008, 50 days after receiving the submission on September 24, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.

Submission Details

510(k) Number K082803 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2008
Decision Date November 13, 2008
Days to Decision 50 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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