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FDA 510(k)

TEKNA MED MYRINGOTOMY DISPOS-OTO KIT

K-Number: K813616 · 1982-01-22

ApplicantHumboldt Products
Decision Date1982-01-22
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TEKNA MED MYRINGOTOMY DISPOS-OTO KIT is the device name listed in this FDA 510(k) record. The listed applicant is Humboldt Products. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K813616. 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 TEKNA MED MYRINGOTOMY DISPOS-OTO KIT?

TEKNA MED MYRINGOTOMY DISPOS-OTO KIT is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Humboldt Products. The 510(k) number is K813616.

When did TEKNA MED MYRINGOTOMY DISPOS-OTO KIT receive FDA 510(k) clearance?

TEKNA MED MYRINGOTOMY DISPOS-OTO KIT received FDA 510(k) clearance on 1982-01-22, under 510(k) number K813616.

Who is the listed applicant for TEKNA MED MYRINGOTOMY DISPOS-OTO KIT?

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 TEKNA MED MYRINGOTOMY DISPOS-OTO KIT?

The FDA product code for TEKNA MED MYRINGOTOMY DISPOS-OTO KIT 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 PISTONSK812562SURGICAL RETRACTOR & ELASTIC STAYS, DISPK802587OTOLOGICAL VENTILATION TUBES

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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