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FDA 510(k)

TYMPASNOSTOMY TUBE

K-Number: K953993 · 1995-09-12

ApplicantHampton Precision Products, Inc.
Decision Date1995-09-12
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TYMPASNOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Hampton Precision Products, Inc.. It received FDA 510(k) clearance on 1995-09-12 under 510(k) number K953993. 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 TYMPASNOSTOMY TUBE?

TYMPASNOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1995-09-12. The listed applicant is Hampton Precision Products, Inc.. The 510(k) number is K953993.

When did TYMPASNOSTOMY TUBE receive FDA 510(k) clearance?

TYMPASNOSTOMY TUBE received FDA 510(k) clearance on 1995-09-12, under 510(k) number K953993.

Who is the listed applicant for TYMPASNOSTOMY TUBE?

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

What is the FDA product code for TYMPASNOSTOMY TUBE?

The FDA product code for TYMPASNOSTOMY TUBE is ETD.

Related Clinical Trials

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.

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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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