Cleared Traditional

K001496 - A.V. FISTULA NEEDLE

K001496 is an FDA 510(k) clearance for A.V. FISTULA NEEDLE, manufactured by Exelint International, Co.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K001496 · Exelint International, Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
78d
Days
Class 2
Risk

K001496 is an FDA 510(k) clearance for the A.V. FISTULA NEEDLE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on August 1, 2000 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Exelint International, Co. devices

FDA 510(k) Submission Details - K001496

510(k) Number K001496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 130d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIE Device Classification - Class 2, Special Controls

Product Code FIE Needle, Fistula
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIE Needle, Fistula

All 41
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K001496.
NIPRO SAFETOUCH II GAMMA
K063721 · Nipro Medical Corp. · Jan 2007
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352 · Jms Co., Ltd. · Sep 2001
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · Nipro Medical Corp. · Nov 2000
MODIFICATION TO JMS APHERESIS NEEDLE
K000843 · Jms Co., Ltd. · Apr 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K000845 · Jms Co., Ltd. · Apr 2000
JMS A. V. FISTULA NEEDLE SET
K990470 · Jms Co., Ltd. · Aug 1999