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FDA 510(k)

TYMPANOSTOMY TUBES (VARIOUS MODELS

K-Number: K820510 · 1982-03-19

ApplicantAbco Dist.
Decision Date1982-03-19
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TYMPANOSTOMY TUBES (VARIOUS MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dist.. It received FDA 510(k) clearance on 1982-03-19 under 510(k) number K820510. 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 TYMPANOSTOMY TUBES (VARIOUS MODELS?

TYMPANOSTOMY TUBES (VARIOUS MODELS is a medical device that received FDA 510(k) clearance on 1982-03-19. The listed applicant is Abco Dist.. The 510(k) number is K820510.

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

TYMPANOSTOMY TUBES (VARIOUS MODELS received FDA 510(k) clearance on 1982-03-19, under 510(k) number K820510.

Who is the listed applicant for TYMPANOSTOMY TUBES (VARIOUS MODELS?

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

What is the FDA product code for TYMPANOSTOMY TUBES (VARIOUS MODELS?

The FDA product code for TYMPANOSTOMY TUBES (VARIOUS MODELS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Abco Dist. 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.

K820332NEEDLE & BLADE COUNTER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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