Cleared Traditional

K201877 - OtoSet- Ear Cleaning System
(FDA 510(k) Clearance)

K201877 · Safkan, Inc. · Ear, Nose, Throat
Nov 2020
Decision
121d
Days
Class 1
Risk

K201877 is an FDA 510(k) clearance for the OtoSet- Ear Cleaning System, a Syringe, Irrigating (non Dental) (Class I — General Controls, product code KYZ), submitted by Safkan, Inc. (Tucson, US). The FDA issued a Cleared decision on November 5, 2020, 121 days after receiving the submission on July 7, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 880.6960.

Submission Details

510(k) Number K201877 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2020
Decision Date November 05, 2020
Days to Decision 121 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code KYZ — Syringe, Irrigating (non Dental)
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6960