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FDA 510(k)

HET BIPOLAR ELECTROCAUTERY FORCEPS

K-Number: K110143 · 2011-06-02

ApplicantHet Systems, LLC
Decision Date2011-06-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HET BIPOLAR ELECTROCAUTERY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Het Systems, LLC. It received FDA 510(k) clearance on 2011-06-02 under 510(k) number K110143. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HET BIPOLAR ELECTROCAUTERY FORCEPS?

HET BIPOLAR ELECTROCAUTERY FORCEPS is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Het Systems, LLC. The 510(k) number is K110143.

When did HET BIPOLAR ELECTROCAUTERY FORCEPS receive FDA 510(k) clearance?

HET BIPOLAR ELECTROCAUTERY FORCEPS received FDA 510(k) clearance on 2011-06-02, under 510(k) number K110143.

Who is the listed applicant for HET BIPOLAR ELECTROCAUTERY FORCEPS?

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

What is the FDA product code for HET BIPOLAR ELECTROCAUTERY FORCEPS?

The FDA product code for HET BIPOLAR ELECTROCAUTERY FORCEPS is GEI.

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 Het Systems, LLC 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.

K121085HET BIPOLAR LIGATOR SYSTEM

Related Devices (Code: GEI)

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.

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Official Source

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