Cleared Traditional

K782021 - A.V. FISTULA NEEDLE SET

K782021 is an FDA 510(k) clearance for A.V. FISTULA NEEDLE SET, manufactured by Cordis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K782021 · Cordis Corp. · Gastroenterology & Urology device
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Mar 1979
Decision
106d
Days
Class 2
Risk

K782021 is an FDA 510(k) clearance for the A.V. FISTULA NEEDLE SET. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979 after a review of 106 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 Cordis Corp. devices

FDA 510(k) Submission Details - K782021

510(k) Number K782021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1978
Decision Date March 21, 1979
Days to Decision 106 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 130d · This submission: 106d
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 41
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K782021.
ARGYLE A-V MEDI-WING HEMODIALYSIS SET
K801618 · Sherwood Medical Co. · Aug 1980
VITAL CATHETER
K791489 · Hospal Medical Corp. · Oct 1979
UNIPUNCTURE CATHETER
K791490 · Hospal Medical Corp. · Oct 1979
AVF SET FOR SINGLE NEEDLE HEMODIALYSIS
K772362 · Terumo America, Inc. · Mar 1978
A.V. FISTULA NEEDLE SET (#344)
K771490 · Sorensen Research · Aug 1977
A.V. FISTULA NEEDLE SET (#364)
K771491 · Sorensen Research · Aug 1977