Cleared Traditional

K854773 - SUPERCATH A.V. FISTULA

K854773 is an FDA 510(k) clearance for SUPERCATH A.V. FISTULA, manufactured by Togo Medikit Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FIE cleared through the Traditional 510(k) pathway after a 130-day FDA review.

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

FDA 510(k) Submission Details - K854773

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 131d · This submission: 130d
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 63
Devices cleared under the same product code (FIE) and FDA review panel - the closest regulatory comparables to K854773.
TERUMO AV FISTULA NEEDLE SET
K891062 · Terumo Medical Corp. · Jun 1989
JMS APHERESIS NEEDLE
K880726 · Jms Co., Ltd. · Mar 1988
MEDISYSTEMS PHERESIS NEEDLE
K862002 · Medisystems Corp. · Jun 1986
JMD AV FISTULA NEEDLE (MODIFICATION)
K860789 · Jms Co., Ltd. · Mar 1986
JMS AV FISTULA NEEDLE
K860241 · Jms Co., Ltd. · Feb 1986
PLUME Y SET
K854951 · Hospal Medical Corp. · Jan 1986