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FDA 510(k)

TYMPANOSTOMY VENTILATION TUBE

K-Number: K971454 · 1997-05-29

ApplicantIkonos Corp.
Decision Date1997-05-29
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TYMPANOSTOMY VENTILATION TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Ikonos Corp.. It received FDA 510(k) clearance on 1997-05-29 under 510(k) number K971454. 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 TYMPANOSTOMY VENTILATION TUBE?

TYMPANOSTOMY VENTILATION TUBE is a medical device that received FDA 510(k) clearance on 1997-05-29. The listed applicant is Ikonos Corp.. The 510(k) number is K971454.

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

TYMPANOSTOMY VENTILATION TUBE received FDA 510(k) clearance on 1997-05-29, under 510(k) number K971454.

Who is the listed applicant for TYMPANOSTOMY VENTILATION TUBE?

The FDA 510(k) record lists Ikonos Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYMPANOSTOMY VENTILATION TUBE?

The FDA product code for TYMPANOSTOMY VENTILATION TUBE is ETD.

Related Clinical Trials

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.

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Other records listing Ikonos Corp. 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.

K971252SEVRAIN CRANIAL CLAMPK971408SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)

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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