Cleared Traditional

FISCH DRILL IRRIGATOR

K861298 · Jedmed Instrument Co. · Ear, Nose, Throat
Apr 1986
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K861298 is an FDA 510(k) clearance for the FISCH DRILL IRRIGATOR, a Irrigator, Sinus (Class I — General Controls, product code KAR), submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on April 23, 1986, 16 days after receiving the submission on April 7, 1986. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K861298 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1986
Decision Date April 23, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code KAR — Irrigator, Sinus
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420