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FDA 510(k)

GOODE T-TUBE, BIOLITE COATED SILICONE/TU

K-Number: K800727 · 1980-04-16

ApplicantXomed, Inc.
Decision Date1980-04-16
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GOODE T-TUBE, BIOLITE COATED SILICONE/TU is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1980-04-16 under 510(k) number K800727. 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 GOODE T-TUBE, BIOLITE COATED SILICONE/TU?

GOODE T-TUBE, BIOLITE COATED SILICONE/TU is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Xomed, Inc.. The 510(k) number is K800727.

When did GOODE T-TUBE, BIOLITE COATED SILICONE/TU receive FDA 510(k) clearance?

GOODE T-TUBE, BIOLITE COATED SILICONE/TU received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800727.

Who is the listed applicant for GOODE T-TUBE, BIOLITE COATED SILICONE/TU?

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

What is the FDA product code for GOODE T-TUBE, BIOLITE COATED SILICONE/TU?

The FDA product code for GOODE T-TUBE, BIOLITE COATED SILICONE/TU is ETD.

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Other records listing Xomed, 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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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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