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)

KEATES IRRIGATION/ASPIRATION/VITREOUS

K-Number: K834437 · 1984-03-30

ApplicantFrigitronics of Connecticut, Inc.
Decision Date1984-03-30
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KEATES IRRIGATION/ASPIRATION/VITREOUS is the device name listed in this FDA 510(k) record. The listed applicant is Frigitronics of Connecticut, Inc.. It received FDA 510(k) clearance on 1984-03-30 under 510(k) number K834437. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KEATES IRRIGATION/ASPIRATION/VITREOUS?

KEATES IRRIGATION/ASPIRATION/VITREOUS is a medical device that received FDA 510(k) clearance on 1984-03-30. The listed applicant is Frigitronics of Connecticut, Inc.. The 510(k) number is K834437.

When did KEATES IRRIGATION/ASPIRATION/VITREOUS receive FDA 510(k) clearance?

KEATES IRRIGATION/ASPIRATION/VITREOUS received FDA 510(k) clearance on 1984-03-30, under 510(k) number K834437.

Who is the listed applicant for KEATES IRRIGATION/ASPIRATION/VITREOUS?

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

What is the FDA product code for KEATES IRRIGATION/ASPIRATION/VITREOUS?

The FDA product code for KEATES IRRIGATION/ASPIRATION/VITREOUS is HQE.

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 Frigitronics of Connecticut, 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.

K891282MIC-100 WITH CRYOPROBESK872362FRIGITRONICS ACC-1000 CAPSULE CUTTERK853308KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000K834577I/A PROBE LINESK840536CRYO SURG 5900K822599KEATES I/A SYSTEM FRIGITRONICS 4000

View all 9 devices →

Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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.

↑