Cleared Traditional

K903440 - VIVAMED FISTULA NEEDLE

K903440 is an FDA 510(k) clearance for VIVAMED FISTULA NEEDLE, manufactured by S.S. Ent.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 629-day FDA review.

K903440 · S.S. Ent. · Gastroenterology & Urology device
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Apr 1992
Decision
629d
Days
Class 2
Risk

K903440 is an FDA 510(k) clearance for the VIVAMED FISTULA NEEDLE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by S.S. Ent. (Weston, US). The FDA issued a Cleared decision on April 20, 1992 after a review of 629 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

FDA 510(k) Submission Details - K903440

510(k) Number K903440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date April 20, 1992
Days to Decision 629 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
498d slower than avg
Panel avg: 131d · This submission: 629d
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 72
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K903440.
BRAUN DIACAN(R) FISTULA NEEDLES
K945850 · B. Braun of America, Inc. · Oct 1995
MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
K932074 · Medisystems Corp. · Feb 1994
JMS APHERESIS NEEDLE
K915174 · Jms Co., Ltd. · Mar 1993
JMS AV FISTULA NEEDLES
K911199 · Jms Co., Ltd. · Aug 1991
MEDISYSTEMS HEMODIALYSIS FISTULA SET
K910734 · Medisystems Corp. · Jun 1991
EXEL A-V FISTULA SET
K903945 · Exel Intl. · Nov 1990