Hummingbird Tympanostomy Tube System— 510(k) K221254

Name: FDA 510(k) clearance K221254
Creator: U.S. Food and Drug Administration
Published: 2022-07-27

Substantially Equivalent

Preceptis Medical, Inc.

FDA 510(k) clearance K221254 for Hummingbird Tympanostomy Tube System, Substantially Equivalent on 2022-07-27. Applicant: Preceptis Medical, Inc.. Device class: 2.

Clearance details

Applicant: Preceptis Medical, Inc.
Product code: Code ETD
Device class: Class 2
Regulation: 21 CFR 874.3880
Advisory panel: Ear, Nose, Throat
Date received: 2022-05-02
Decision date: 2022-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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