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FDA 510(k)

SILICONE TYMPANOSTOMY TUBES

K-Number: K932166 · 1993-07-26

ApplicantSmith & Nephew Richards, Inc.
Decision Date1993-07-26
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILICONE TYMPANOSTOMY TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1993-07-26 under 510(k) number K932166. 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 SILICONE TYMPANOSTOMY TUBES?

SILICONE TYMPANOSTOMY TUBES is a medical device that received FDA 510(k) clearance on 1993-07-26. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K932166.

When did SILICONE TYMPANOSTOMY TUBES receive FDA 510(k) clearance?

SILICONE TYMPANOSTOMY TUBES received FDA 510(k) clearance on 1993-07-26, under 510(k) number K932166.

Who is the listed applicant for SILICONE TYMPANOSTOMY TUBES?

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

What is the FDA product code for SILICONE TYMPANOSTOMY TUBES?

The FDA product code for SILICONE TYMPANOSTOMY TUBES is ETD.

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Other records listing Smith & Nephew Richards, 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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