Cleared Traditional

WILTEK VARICES INJECTION NEEDLE

K894868 · Wiltek Medical, Inc. · Gastroenterology & Urology

Dec 1989

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K894868 is an FDA 510(k) clearance for the WILTEK VARICES INJECTION NEEDLE, a Endoscopic Injection Needle, Gastroenterology-urology (Class II — Special Controls, product code FBK), submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on December 21, 1989, 143 days after receiving the submission on July 31, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K894868 FDA.gov
FDA Decision	Cleared 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	—

Device Classification

Product Code	FBK — Endoscopic Injection Needle, Gastroenterology-urology
Device Class	Class II — 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.