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FDA 510(k)

TYMPANOSTOMY (VENTILATION) TUBE

K-Number: K941407 · 1995-03-14

ApplicantXomed-Treace, Inc.
Decision Date1995-03-14
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 Xomed-Treace, Inc.. It received FDA 510(k) clearance on 1995-03-14 under 510(k) number K941407. 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 1995-03-14. The listed applicant is Xomed-Treace, Inc.. The 510(k) number is K941407.

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

TYMPANOSTOMY (VENTILATION) TUBE received FDA 510(k) clearance on 1995-03-14, under 510(k) number K941407.

Who is the listed applicant for TYMPANOSTOMY (VENTILATION) TUBE?

The FDA 510(k) record lists Xomed-Treace, Inc. 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

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Other records listing Xomed-Treace, 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.

K940028ENDOSCOPE SHEATHK945659BLACKSTAR(TM) STAR SYSTEMK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEK933672XOMED-TREACE SCOPESHEATHK934426NERVE INTEGRITY MONITOR-2 (NIM-2 XL)K933105XOMED-TREACE RIGID ROD LENS ENDOSCOPE

View all 12 devices →

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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