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FDA 510(k)

MYRINGOTOMY TUBE - BOBBIN WITH TAB

K-Number: K972400 · 1997-07-23

ApplicantMednet Locator, Inc.
Decision Date1997-07-23
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MYRINGOTOMY TUBE - BOBBIN WITH TAB is the device name listed in this FDA 510(k) record. The listed applicant is Mednet Locator, Inc.. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K972400. 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 MYRINGOTOMY TUBE - BOBBIN WITH TAB?

MYRINGOTOMY TUBE - BOBBIN WITH TAB is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Mednet Locator, Inc.. The 510(k) number is K972400.

When did MYRINGOTOMY TUBE - BOBBIN WITH TAB receive FDA 510(k) clearance?

MYRINGOTOMY TUBE - BOBBIN WITH TAB received FDA 510(k) clearance on 1997-07-23, under 510(k) number K972400.

Who is the listed applicant for MYRINGOTOMY TUBE - BOBBIN WITH TAB?

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

What is the FDA product code for MYRINGOTOMY TUBE - BOBBIN WITH TAB?

The FDA product code for MYRINGOTOMY TUBE - BOBBIN WITH TAB is ETD.

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Other records listing Mednet Locator, 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.

K001406HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESESK001404GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTONK974174ULTRABURK972734PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)K972737CAUSSE PISTONK972735TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)

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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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