Cleared Traditional

K771491 - A.V. FISTULA NEEDLE SET (#364)

K771491 is an FDA 510(k) clearance for A.V. FISTULA NEEDLE SET (#364), manufactured by Sorensen Research. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K771491 · Sorensen Research · Gastroenterology & Urology device
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Aug 1977
Decision
11d
Days
Class 2
Risk

K771491 is an FDA 510(k) clearance for the A.V. FISTULA NEEDLE SET (#364). Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on August 16, 1977 after a review of 11 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sorensen Research devices

FDA 510(k) Submission Details - K771491

510(k) Number K771491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1977
Decision Date August 16, 1977
Days to Decision 11 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
120d faster than avg
Panel avg: 131d · This submission: 11d
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 51
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K771491.
A.V. FISTULA NEEDLE SET
K782021 · Cordis Corp. · Mar 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 (#351)
K771492 · Sorensen Research · Aug 1977
A.V. FISTULA NEEDLE SET (#341)
K771493 · Sorensen Research · Aug 1977
A.V. FISTULA NEEDLE SET (354)
K771494 · Sorensen Research · Aug 1977