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FDA 510(k)

OTOMEDICS SOFT TYMPANOSTOMY TUBE

K-Number: K071178 · 2007-06-22

ApplicantOtomedics Advanced Medical Technologies, Ltd.
Decision Date2007-06-22
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOMEDICS SOFT TYMPANOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Otomedics Advanced Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2007-06-22 under 510(k) number K071178. 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 OTOMEDICS SOFT TYMPANOSTOMY TUBE?

OTOMEDICS SOFT TYMPANOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 2007-06-22. The listed applicant is Otomedics Advanced Medical Technologies, Ltd.. The 510(k) number is K071178.

When did OTOMEDICS SOFT TYMPANOSTOMY TUBE receive FDA 510(k) clearance?

OTOMEDICS SOFT TYMPANOSTOMY TUBE received FDA 510(k) clearance on 2007-06-22, under 510(k) number K071178.

Who is the listed applicant for OTOMEDICS SOFT TYMPANOSTOMY TUBE?

The FDA 510(k) record lists Otomedics Advanced Medical Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTOMEDICS SOFT TYMPANOSTOMY TUBE?

The FDA product code for OTOMEDICS SOFT TYMPANOSTOMY TUBE is ETD.

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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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