Cleared Traditional

K023162 - FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

K023162 is an FDA 510(k) clearance for FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS, manufactured by Fresenius Medical Care. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K023162 · Fresenius Medical Care · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
178d
Days
Class 2
Risk

K023162 is an FDA 510(k) clearance for the FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Fresenius Medical Care (Lexington, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 178 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 Fresenius Medical Care devices

FDA 510(k) Submission Details - K023162

510(k) Number K023162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2002
Decision Date March 20, 2003
Days to Decision 178 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
48d slower than avg
Panel avg: 130d · This submission: 178d
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 47
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K023162.
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
K062953 · Medisystems Corp. · Feb 2007
NIPRO BIOHOLE NEEDLE
K063368 · Nipro Medical Corp. · Feb 2007
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