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FDA 510(k)

TYMPANOSTOMY TUBES & VARIOUS TYPES

K-Number: K822017 · 1982-10-27

ApplicantKelleher Corp.
Decision Date1982-10-27
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TYMPANOSTOMY TUBES & VARIOUS TYPES is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822017. 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 TUBES & VARIOUS TYPES?

TYMPANOSTOMY TUBES & VARIOUS TYPES is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Kelleher Corp.. The 510(k) number is K822017.

When did TYMPANOSTOMY TUBES & VARIOUS TYPES receive FDA 510(k) clearance?

TYMPANOSTOMY TUBES & VARIOUS TYPES received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822017.

Who is the listed applicant for TYMPANOSTOMY TUBES & VARIOUS TYPES?

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

What is the FDA product code for TYMPANOSTOMY TUBES & VARIOUS TYPES?

The FDA product code for TYMPANOSTOMY TUBES & VARIOUS TYPES is ETD.

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Other records listing Kelleher 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.

K822618EMERGENCY TRACHEOSTOMY INSTRUMENT SETK822268NAGASHIMA NS-III ELECTRONYSTAGMOGRAPHK823083ELECTROSURGICAL UNITK822252ENT TREATMENT UNITSK823111NYSTYMOGRAPH ACCESSK822272HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS

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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

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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