Cleared Traditional

K082882 - A.V. FISTULA BLUNT NEEDLE SET

K082882 is an FDA 510(k) clearance for A.V. FISTULA BLUNT NEEDLE SET, manufactured by Jms North America Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K082882 · Jms North America Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jan 2009
Decision
113d
Days
Class 2
Risk

K082882 is an FDA 510(k) clearance for the A.V. FISTULA BLUNT NEEDLE SET. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Jms North America Corp. (Great Neck, US). The FDA issued a Cleared decision on January 21, 2009 after a review of 113 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 North America Corp. devices

FDA 510(k) Submission Details - K082882

510(k) Number K082882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date January 21, 2009
Days to Decision 113 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 130d · This submission: 113d
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 29
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K082882.
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