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)

POLAR WAND

K-Number: K021387 · 2002-07-31

ApplicantChek-Med Systems
Decision Date2002-07-31
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLAR WAND is the device name listed in this FDA 510(k) record. The listed applicant is Chek-Med Systems. It received FDA 510(k) clearance on 2002-07-31 under 510(k) number K021387. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLAR WAND?

POLAR WAND is a medical device that received FDA 510(k) clearance on 2002-07-31. The listed applicant is Chek-Med Systems. The 510(k) number is K021387.

When did POLAR WAND receive FDA 510(k) clearance?

POLAR WAND received FDA 510(k) clearance on 2002-07-31, under 510(k) number K021387.

Who is the listed applicant for POLAR WAND?

The FDA 510(k) record lists Chek-Med Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLAR WAND?

The FDA product code for POLAR WAND is GEH.

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 Chek-Med Systems 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.

K041783POLAR WANDK993951SPOT ENDOSCOPIC MARKER

Related Devices (Code: GEH)

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.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

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.

↑