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FDA 510(k)

GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE

K-Number: K853641 · 1986-01-06

ApplicantXomed, Inc.
Decision Date1986-01-06
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1986-01-06 under 510(k) number K853641. 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 GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE?

GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1986-01-06. The listed applicant is Xomed, Inc.. The 510(k) number is K853641.

When did GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE receive FDA 510(k) clearance?

GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE received FDA 510(k) clearance on 1986-01-06, under 510(k) number K853641.

Who is the listed applicant for GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE?

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 GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE?

The FDA product code for GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBE 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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