Cleared Traditional

K002352 - JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE

K002352 is an FDA 510(k) clearance for JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE, manufactured by Jms Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K002352 · Jms Co., Ltd. · Gastroenterology & Urology device
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Sep 2001
Decision
400d
Days
Class 2
Risk

K002352 is an FDA 510(k) clearance for the JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE. 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 September 6, 2001 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K002352

510(k) Number K002352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2000
Decision Date September 06, 2001
Days to Decision 400 days
Submission Type Traditional
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
269d slower than avg
Panel avg: 131d · This submission: 400d
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 K002352.
FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS
K023162 · Fresenius Medical Care · Mar 2003
SHARGHP A.V. FISTULA NEEDLE SET
K013384 · Shargh Pharmaceutical Co., Inc. · Jan 2002
EXCEL A.V FISUTAL NEEDLE SET
K013037 · Exelint Intl. Co. · Dec 2001
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
K002352 · JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
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