Cleared Traditional

Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)

K171505 · Dimesol, Inc. · Gastroenterology & Urology

May 2018

Decision

359d

Days

Class 2

Risk

About This 510(k) Submission

K171505 is an FDA 510(k) clearance for the Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series), a Needle, Fistula (Class II — Special Controls, product code FIE), submitted by Dimesol, Inc. (Lewisberry, US). The FDA issued a Cleared decision on May 17, 2018, 359 days after receiving the submission on May 23, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K171505 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2017
Decision Date	May 17, 2018
Days to Decision	359 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF