Cleared Special

K000843 - MODIFICATION TO JMS APHERESIS NEEDLE

K000843 is an FDA 510(k) clearance for MODIFICATION TO JMS APHERESIS NEEDLE, manufactured by Jms Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Special 510(k) pathway after a 26-day FDA review.

K000843 · Jms Co., Ltd. · Gastroenterology & Urology device
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Apr 2000
Decision
26d
Days
Class 2
Risk

K000843 is an FDA 510(k) clearance for the MODIFICATION TO JMS APHERESIS NEEDLE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Jms Co., Ltd. (Hiroshima, JP). The FDA issued a Cleared decision on April 10, 2000 after a review of 26 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 - K000843

510(k) Number K000843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2000
Decision Date April 10, 2000
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 131d · This submission: 26d
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 K000843.
RENAX A.V. FISTULA NEEDLE SETS
K003123 · Sunder Biomedical Tech. Co., Ltd. · May 2001
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · Nipro Medical Corp. · Nov 2000
A.V. FISTULA NEEDLE
K001496 · Exelint International, Co. · Aug 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K000845 · Jms Co., Ltd. · Apr 2000
MEDISYSTEMS BUTTONHOLE NEEDLE SETS
K990803 · Medisystems Corp. · Jan 2000
BIOTEQUE A.V. FISTULA NEEDLE SET
K993118 · Bioteque Corp. · Dec 1999
K000843 · MODIFICATION TO JMS APHERESIS NEEDLE
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