Cleared Traditional

K062953 - MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE

K062953 is an FDA 510(k) clearance for MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEE..., manufactured by Medisystems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K062953 · Medisystems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
136d
Days
Class 2
Risk

K062953 is an FDA 510(k) clearance for the MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Medisystems Corp. (Seattle, US). The FDA issued a Cleared decision on February 12, 2007 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K062953

510(k) Number K062953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date February 12, 2007
Days to Decision 136 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 131d · This submission: 136d
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 79
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K062953.
JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
K093637 · Jms North America Corp. · Feb 2010
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
K093985 · Nipro Medical Corp. · Jan 2010
A.V. FISTULA BLUNT NEEDLE SET
K082882 · Jms North America Corp. · Jan 2009
NIPRO BIOHOLE NEEDLE
K063368 · Nipro Medical Corp. · Feb 2007
NIPRO SAFETOUCH II GAMMA
K063721 · Nipro Medical Corp. · Jan 2007
SUPERCATH V
K052267 · Togo Medikit Co., Ltd. · Oct 2006
K062953 · MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
Download PDF FDA Summary Medisystems Corp.