Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OTOLOGICAL VENTILATION TUBES-VARIOUS

K-Number: K830228 · 1983-03-07

ApplicantMicromedics, Inc.
Decision Date1983-03-07
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOLOGICAL VENTILATION TUBES-VARIOUS is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc.. It received FDA 510(k) clearance on 1983-03-07 under 510(k) number K830228. 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 OTOLOGICAL VENTILATION TUBES-VARIOUS?

OTOLOGICAL VENTILATION TUBES-VARIOUS is a medical device that received FDA 510(k) clearance on 1983-03-07. The listed applicant is Micromedics, Inc.. The 510(k) number is K830228.

When did OTOLOGICAL VENTILATION TUBES-VARIOUS receive FDA 510(k) clearance?

OTOLOGICAL VENTILATION TUBES-VARIOUS received FDA 510(k) clearance on 1983-03-07, under 510(k) number K830228.

Who is the listed applicant for OTOLOGICAL VENTILATION TUBES-VARIOUS?

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

What is the FDA product code for OTOLOGICAL VENTILATION TUBES-VARIOUS?

The FDA product code for OTOLOGICAL VENTILATION TUBES-VARIOUS 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 Micromedics, 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.

K241739Endoscopic Applicator, 41 cmK123847MALLEABLE TIP ENDOSCOPIC APPLICATORK122526360 GAS ASSISTED ENDOSCOPIC APPLICATORK120608ENDOSCOPIC APPLICATORK102563SINGLE CANNULA EXTENDED APPLICATORK100754GRAFT DELIVERY SYSTEM MODEL SA-6115

View all 29 devices →

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.

↑