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)

FLEX-LOOP FLEXIBLE EAR CORETTE

K-Number: K852039 · 1985-06-11

ApplicantBionix Corp.
Decision Date1985-06-11
Product CodeJYG
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FLEX-LOOP FLEXIBLE EAR CORETTE is the device name listed in this FDA 510(k) record. The listed applicant is Bionix Corp.. It received FDA 510(k) clearance on 1985-06-11 under 510(k) number K852039. The device is classified under product code JYG. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEX-LOOP FLEXIBLE EAR CORETTE?

FLEX-LOOP FLEXIBLE EAR CORETTE is a medical device that received FDA 510(k) clearance on 1985-06-11. The listed applicant is Bionix Corp.. The 510(k) number is K852039.

When did FLEX-LOOP FLEXIBLE EAR CORETTE receive FDA 510(k) clearance?

FLEX-LOOP FLEXIBLE EAR CORETTE received FDA 510(k) clearance on 1985-06-11, under 510(k) number K852039.

Who is the listed applicant for FLEX-LOOP FLEXIBLE EAR CORETTE?

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

What is the FDA product code for FLEX-LOOP FLEXIBLE EAR CORETTE?

The FDA product code for FLEX-LOOP FLEXIBLE EAR CORETTE is JYG.

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 Bionix Corp. 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.

K860606RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM

Related Devices (Code: JYG)

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.

K932609EAR CURETTEEar Tech, Inc.K841354CURETTETreace Medical, Inc.K841001EAR CURETTE, VARIOUSPremier Dental Products Co.K823916WAX CURETTE TIPTreace Medical, Inc.K822273ENT CURRETTESKelleher Corp.K822006OPERATIVE EAR CURRETTES & RELATED ITEMKelleher Corp.

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.

↑