Cleared Traditional

SUPERCATH A.V. FISTULA (K854773) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854773 · Togo Medikit Co., Ltd. · Gastroenterology & Urology device
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Apr 1986
Decision
130d
Days
Class 2
Risk

K854773 is an FDA 510(k) clearance for the SUPERCATH A.V. FISTULA. Classified as Needle, Fistula (product code FIE), Class II - Special Controls.

Submitted by Togo Medikit Co., Ltd. (Chiyoda-Ku Tokyo101 Japan, JP). The FDA issued a Cleared decision on April 8, 1986 after a review of 130 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 Togo Medikit Co., Ltd. devices

Submission Details

510(k) Number K854773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1985
Decision Date April 08, 1986
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K854773.
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
K171505 · Dimesol, Inc. · May 2018
ARTERIOVENOUS FISTULA SETS
K900125 · Baxter Healthcare Corp · Jan 1990
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989
DUAL FLOW NEEDLE
K832136 · Travenol Laboratories, S.A. · Oct 1983
ARGYLE A-V MEDI-WING HEMODIALYSIS SET
K801618 · Sherwood Medical Co. · Aug 1980
A.V. FISTULA NEEDLE SET
K782021 · Cordis Corp. · Mar 1979