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FDA 510(k)

TYTAN GROMMET VENT TUBE, .040

K-Number: K822366 · 1982-09-02

ApplicantTreace Medical, Inc.
Decision Date1982-09-02
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TYTAN GROMMET VENT TUBE, .040 is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1982-09-02 under 510(k) number K822366. 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 TYTAN GROMMET VENT TUBE, .040?

TYTAN GROMMET VENT TUBE, .040 is a medical device that received FDA 510(k) clearance on 1982-09-02. The listed applicant is Treace Medical, Inc.. The 510(k) number is K822366.

When did TYTAN GROMMET VENT TUBE, .040 receive FDA 510(k) clearance?

TYTAN GROMMET VENT TUBE, .040 received FDA 510(k) clearance on 1982-09-02, under 510(k) number K822366.

Who is the listed applicant for TYTAN GROMMET VENT TUBE, .040?

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

What is the FDA product code for TYTAN GROMMET VENT TUBE, .040?

The FDA product code for TYTAN GROMMET VENT TUBE, .040 is ETD.

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Other records listing Treace Medical, Inc. as applicant

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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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