Cleared Traditional

K894868 - WILTEK VARICES INJECTION NEEDLE

K894868 is an FDA 510(k) clearance for WILTEK VARICES INJECTION NEEDLE, manufactured by Wiltek Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FBK cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K894868 · Wiltek Medical, Inc. · Gastroenterology & Urology device
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Dec 1989
Decision
143d
Days
Class 2
Risk

K894868 is an FDA 510(k) clearance for the WILTEK VARICES INJECTION NEEDLE. Classified as Endoscopic Injection Needle, Gastroenterology-urology (product code FBK), Class II - Special Controls.

Submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on December 21, 1989 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - 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 Wiltek Medical, Inc. devices

FDA 510(k) Submission Details - K894868

510(k) Number K894868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date December 21, 1989
Days to Decision 143 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
13d slower than avg
Panel avg: 130d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FBK Device Classification - Class 2, Special Controls

Product Code FBK Endoscopic Injection Needle, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Inserted Through Endoscope For Injection Of A Solution, Gas, Or Implantable Materials Into Gi Or Gu Tissue.
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 - FBK Endoscopic Injection Needle, Gastroenterology-urology

All 52
Devices cleared under the same product code (FBK) and FDA review panel - the closest regulatory comparables to K894868.
NEEDLE
K924102 · United States Endoscopy Group, Inc. · Nov 1992
WILSON-COOK ASPIRATION HANDLE
K903668 · Wilson-Cook Medical, Inc. · Oct 1990
NM INJECTION NEEDLES
K902736 · Olympus Corp. · Aug 1990
TRANSENDOSCOPIC ASPIRATION NEEDLE
K883093 · Endovations · Dec 1988
WASHING/INJECTION NEEDLE
K872060 · Endovations · Jul 1987
WILLIAMS FLEXIBLE CYSTOSCOPIC INJECTION NEEDLE
K865086 · Van-Tec, Inc. · Mar 1987