Cleared Traditional

K052298 - CYSTOGLIDE INTRODUCER SHEATH
(FDA 510(k) Clearance)

K052298 · Percutaneous Systems, Incorporated · Gastroenterology & Urology device

Dec 2006

Decision

476d

Days

Class 2

Risk

K052298 is an FDA 510(k) clearance for the CYSTOGLIDE INTRODUCER SHEATH. This device is classified as a Accessories, Catheter, G-u (Class II - Special Controls, product code KNY).

Submitted by Percutaneous Systems, Incorporated (Mountain View, US). The FDA issued a Cleared decision on December 12, 2006, 476 days after receiving the submission on August 23, 2005.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K052298 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 23, 2005
Decision Date	December 12, 2006
Days to Decision	476 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF