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FDA 510(k)

Hummingbird Tympanostomy Tube System

K-Number: K200952 · 2020-06-05

ApplicantPreceptis Medical, Inc.
Decision Date2020-06-05
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Hummingbird Tympanostomy Tube System is the device name listed in this FDA 510(k) record. The listed applicant is Preceptis Medical, Inc.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K200952. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hummingbird Tympanostomy Tube System?

Hummingbird Tympanostomy Tube System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Preceptis Medical, Inc.. The 510(k) number is K200952.

When did Hummingbird Tympanostomy Tube System receive FDA 510(k) clearance?

Hummingbird Tympanostomy Tube System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K200952.

Who is the listed applicant for Hummingbird Tympanostomy Tube System?

The FDA 510(k) record lists Preceptis Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hummingbird Tympanostomy Tube System?

The FDA product code for Hummingbird Tympanostomy Tube System is ETD.

Other records listing Preceptis Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221254Hummingbird Tympanostomy Tube System

Related Devices (Code: ETD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))Aventamed DacK232702Solo+ Tympanostomy Tube Device (TTD)Aventamed DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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