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)

ENT MALLETS

K-Number: K822204 · 1982-09-17

ApplicantKelleher Corp.
Decision Date1982-09-17
Product CodeGFJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENT MALLETS is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822204. The device is classified under product code GFJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENT MALLETS?

ENT MALLETS is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Kelleher Corp.. The 510(k) number is K822204.

When did ENT MALLETS receive FDA 510(k) clearance?

ENT MALLETS received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822204.

Who is the listed applicant for ENT MALLETS?

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

What is the FDA product code for ENT MALLETS?

The FDA product code for ENT MALLETS is GFJ.

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 Kelleher 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.

K822618EMERGENCY TRACHEOSTOMY INSTRUMENT SETK822268NAGASHIMA NS-III ELECTRONYSTAGMOGRAPHK823083ELECTROSURGICAL UNITK822252ENT TREATMENT UNITSK823111NYSTYMOGRAPH ACCESSK822272HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS

View all 94 devices →

Related Devices (Code: GFJ)

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.

K85178929-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOYArtiberiaK844017MICROTENS 7757 T.E.N.S. STIMULATORRabar, 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.

↑