Cleared Traditional

K990803 - MEDISYSTEMS BUTTONHOLE NEEDLE SETS

K990803 is an FDA 510(k) clearance for MEDISYSTEMS BUTTONHOLE NEEDLE SETS, manufactured by Medisystems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K990803 · Medisystems Corp. · Gastroenterology & Urology device
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Jan 2000
Decision
302d
Days
Class 2
Risk

K990803 is an FDA 510(k) clearance for the MEDISYSTEMS BUTTONHOLE NEEDLE SETS. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Medisystems Corp. (Washington, US). The FDA issued a Cleared decision on January 6, 2000 after a review of 302 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.

View all Medisystems Corp. devices

FDA 510(k) Submission Details - K990803

510(k) Number K990803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1999
Decision Date January 06, 2000
Days to Decision 302 days
Submission Type Traditional
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
171d slower than avg
Panel avg: 131d · This submission: 302d
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 K990803.
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · Nipro Medical Corp. · Nov 2000
MODIFICATION TO JMS APHERESIS NEEDLE
K000843 · Jms Co., Ltd. · Apr 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K000845 · Jms Co., Ltd. · Apr 2000
BIOTEQUE A.V. FISTULA NEEDLE SET
K993118 · Bioteque Corp. · Dec 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K992653 · Diasol, Inc. · Oct 1999
JMS A. V. FISTULA NEEDLE SET
K990470 · Jms Co., Ltd. · Aug 1999