Cleared Traditional

K003123 - RENAX A.V. FISTULA NEEDLE SETS

K003123 is an FDA 510(k) clearance for RENAX A.V. FISTULA NEEDLE SETS, manufactured by Sunder Biomedical Tech. Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K003123 · Sunder Biomedical Tech. Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
211d
Days
Class 2
Risk

K003123 is an FDA 510(k) clearance for the RENAX A.V. FISTULA NEEDLE SETS. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Sunder Biomedical Tech. Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on May 4, 2001 after a review of 211 days - an extended review 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: 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.

View all Sunder Biomedical Tech. Co., Ltd. devices

FDA 510(k) Submission Details - K003123

510(k) Number K003123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2000
Decision Date May 04, 2001
Days to Decision 211 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 130d · This submission: 211d
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 29
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K003123.
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
K093985 · Nipro Medical Corp. · Jan 2010
NIPRO BIOHOLE NEEDLE
K063368 · Nipro Medical Corp. · Feb 2007
NIPRO SAFETOUCH II GAMMA
K063721 · Nipro Medical Corp. · Jan 2007
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · Nipro Medical Corp. · Nov 2000
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
K991623 · Nipro Medical Corp. · Aug 1999
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990