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FDA 510(k)

HET BIPOLAR LIGATOR SYSTEM

K-Number: K121085 · 2012-11-20

ApplicantHet Systems, LLC
Decision Date2012-11-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HET BIPOLAR LIGATOR SYSTEM 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 2012-11-20 under 510(k) number K121085. 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 LIGATOR SYSTEM?

HET BIPOLAR LIGATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Het Systems, LLC. The 510(k) number is K121085.

When did HET BIPOLAR LIGATOR SYSTEM receive FDA 510(k) clearance?

HET BIPOLAR LIGATOR SYSTEM received FDA 510(k) clearance on 2012-11-20, under 510(k) number K121085.

Who is the listed applicant for HET BIPOLAR LIGATOR SYSTEM?

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 LIGATOR SYSTEM?

The FDA product code for HET BIPOLAR LIGATOR SYSTEM 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.

K110143HET BIPOLAR ELECTROCAUTERY FORCEPS

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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