Cleared Special

K100520 - NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER

K100520 is an FDA 510(k) clearance for NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB R..., manufactured by Nipro Medical Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Special 510(k) pathway after a 22-day FDA review.

K100520 · Nipro Medical Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
22d
Days
Class 2
Risk

K100520 is an FDA 510(k) clearance for the NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on March 17, 2010 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100520

510(k) Number K100520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2010
Decision Date March 17, 2010
Days to Decision 22 days
Submission Type Special
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
109d faster than avg
Panel avg: 131d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 K100520.
JMS APHERESIS NEEDLE SET WINGEATER(R) V2
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K110157 · JMS North America Corporation · Feb 2011
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
K100520 · NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
Download PDF FDA Summary Nipro Medical Corpora…