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FDA 510(k)

OTOLOGICAL VENTILATION TUBES

K-Number: K802587 · 1980-11-12

ApplicantHumboldt Products
Decision Date1980-11-12
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOLOGICAL VENTILATION TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Humboldt Products. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802587. 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 OTOLOGICAL VENTILATION TUBES?

OTOLOGICAL VENTILATION TUBES is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Humboldt Products. The 510(k) number is K802587.

When did OTOLOGICAL VENTILATION TUBES receive FDA 510(k) clearance?

OTOLOGICAL VENTILATION TUBES received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802587.

Who is the listed applicant for OTOLOGICAL VENTILATION TUBES?

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

What is the FDA product code for OTOLOGICAL VENTILATION TUBES?

The FDA product code for OTOLOGICAL VENTILATION TUBES 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 Humboldt Products 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.

K832540DRUMTO STAPES PROSTHESISK823483STAINLESS STEEL PISTONSK813616TEKNA MED MYRINGOTOMY DISPOS-OTO KITK812562SURGICAL RETRACTOR & ELASTIC STAYS, DISP

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

View on FDA Database →

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

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