Cleared Traditional

K844343 - TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE

K844343 is an FDA 510(k) clearance for TOP SINGLE USE U.T.W. A-V FISTULA NEEDL..., manufactured by Top Surgical Manufacturers Co.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K844343 · Top Surgical Manufacturers Co. · Gastroenterology & Urology device
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Jan 1985
Decision
60d
Days
Class 2
Risk

K844343 is an FDA 510(k) clearance for the TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Top Surgical Manufacturers Co. (Littleton, US). The FDA issued a Cleared decision on January 8, 1985 after a review of 60 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 Top Surgical Manufacturers Co. devices

FDA 510(k) Submission Details - K844343

510(k) Number K844343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1984
Decision Date January 08, 1985
Days to Decision 60 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
71d faster than avg
Panel avg: 131d · This submission: 60d
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 66
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K844343.
JMS AV FISTULA NEEDLE
K860241 · Jms Co., Ltd. · Feb 1986
PLUME Y SET
K854951 · Hospal Medical Corp. · Jan 1986
HOSPAL FISTULA NEEDLE
K851453 · Hospal Medical Corp. · Apr 1985
DUAL FLOW NEEDLE
K832136 · Travenol Laboratories, S.A. · Oct 1983
MEDISYSTEMS FISTULA NEEDLE
K811838 · Medisystems Corp. · Sep 1981
GAMBRO A-V FISTULA NEEDLE SET
K802956 · Gambro, Inc. · Dec 1980