Cleared Traditional

K970962 - JMS AV FISTULA NEEDLE

K970962 is an FDA 510(k) clearance for JMS AV FISTULA NEEDLE, 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 143-day FDA review.

K970962 · Jms Co., Ltd. · Gastroenterology & Urology device
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Aug 1997
Decision
143d
Days
Class 2
Risk

K970962 is an FDA 510(k) clearance for the JMS AV FISTULA NEEDLE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Jms Co., Ltd. (Hiroshima, 730, JP). The FDA issued a Cleared decision on August 7, 1997 after a review of 143 days - within the typical 510(k) review window.

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 Jms Co., Ltd. devices

FDA 510(k) Submission Details - K970962

510(k) Number K970962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1997
Decision Date August 07, 1997
Days to Decision 143 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
12d slower than avg
Panel avg: 131d · This submission: 143d
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 63
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K970962.
JMS APHERESIS NEEDLE
K990510 · Jms Co., Ltd. · Aug 1999
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
K991623 · Nipro Medical Corp. · Aug 1999
JMS APHERESIS NEEDLE
K974902 · Jms Co., Ltd. · Mar 1998
NIPRO ARTERIAL VENOUS FISTULA NEEDLE
K955182 · Nissho Corp. · Jun 1996
BRAUN DIACAN(R) FISTULA NEEDLES
K945850 · B. Braun of America, Inc. · Oct 1995
MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
K932074 · Medisystems Corp. · Feb 1994