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FDA 510(k)

C-FLEX VENT TUBES

K-Number: K943190 · 1994-08-24

ApplicantMicromed Development Corp.
Decision Date1994-08-24
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

C-FLEX VENT TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Micromed Development Corp.. It received FDA 510(k) clearance on 1994-08-24 under 510(k) number K943190. 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 C-FLEX VENT TUBES?

C-FLEX VENT TUBES is a medical device that received FDA 510(k) clearance on 1994-08-24. The listed applicant is Micromed Development Corp.. The 510(k) number is K943190.

When did C-FLEX VENT TUBES receive FDA 510(k) clearance?

C-FLEX VENT TUBES received FDA 510(k) clearance on 1994-08-24, under 510(k) number K943190.

Who is the listed applicant for C-FLEX VENT TUBES?

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

What is the FDA product code for C-FLEX VENT TUBES?

The FDA product code for C-FLEX VENT TUBES is ETD.

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Other records listing Micromed Development Corp. 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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