Cleared Traditional

A.V. FISTULA NEEDLE

K001496 · Exelint International, Co. · Gastroenterology & Urology
Aug 2000
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K001496 is an FDA 510(k) clearance for the A.V. FISTULA NEEDLE, a Needle, Fistula (Class II — Special Controls, product code FIE), submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on August 1, 2000, 78 days after receiving the submission on May 15, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K001496 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2000
Decision Date August 01, 2000
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FIE — Needle, Fistula
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

Similar Devices — FIE Needle, Fistula

All 78
JMS CAVEO A.V. Fistula Needle Set
K251877 · JMS North America Corporation · Aug 2025
DORA Disposable A.V. Fistula Needle Sets
K213015 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Apr 2022
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
K171505 · Dimesol, Inc. · May 2018
DORA Disposable A.V. Fistula Needle Sets
K163025 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Jul 2017
JMS Harmony A.V. Fistula Needle Set
K151017 · JMS North America Corporation · May 2015
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
K131950 · Summit International Medical Technologies, Inc. · Jan 2015