Cleared Traditional

Hummingbird Tympanostomy Tube System

K221254 · Preceptis Medical, Inc. · Ear, Nose, Throat

Jul 2022

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K221254 is an FDA 510(k) clearance for the Hummingbird Tympanostomy Tube System, a Tube, Tympanostomy (Class II — Special Controls, product code ETD), submitted by Preceptis Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 27, 2022, 86 days after receiving the submission on May 2, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3880.

Submission Details

510(k) Number	K221254 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2022
Decision Date	July 27, 2022
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF