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FDA 510(k)

TYMPANOSTOMY TUBE

K-Number: K082188 · 2008-09-19

ApplicantAcclarent, Inc.
Decision Date2008-09-19
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TYMPANOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Acclarent, Inc.. It received FDA 510(k) clearance on 2008-09-19 under 510(k) number K082188. 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 TUBE?

TYMPANOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 2008-09-19. The listed applicant is Acclarent, Inc.. The 510(k) number is K082188.

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

TYMPANOSTOMY TUBE received FDA 510(k) clearance on 2008-09-19, under 510(k) number K082188.

Who is the listed applicant for TYMPANOSTOMY TUBE?

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

What is the FDA product code for TYMPANOSTOMY TUBE?

The FDA product code for TYMPANOSTOMY TUBE is ETD.

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Other records listing Acclarent, Inc. 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.

K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemK230742ACCLARENT AERA Eustachian Tube Dilation SystemK231862TruDi® Navigation System V3 (FG-2000-00)K221037TruDi Shaver BladeK201115Next Generation Balloon Dilation SystemK201174TruDi Curette

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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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