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FDA 510(k)

THE ABLATION SYSTEM

K-Number: K121858 · 2012-11-05

ApplicantHalt Medical, Inc.
Decision Date2012-11-05
Product CodeHFG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

THE ABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Halt Medical, Inc.. It received FDA 510(k) clearance on 2012-11-05 under 510(k) number K121858. The device is classified under product code HFG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ABLATION SYSTEM?

THE ABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-05. The listed applicant is Halt Medical, Inc.. The 510(k) number is K121858.

When did THE ABLATION SYSTEM receive FDA 510(k) clearance?

THE ABLATION SYSTEM received FDA 510(k) clearance on 2012-11-05, under 510(k) number K121858.

Who is the listed applicant for THE ABLATION SYSTEM?

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

What is the FDA product code for THE ABLATION SYSTEM?

The FDA product code for THE ABLATION SYSTEM is HFG.

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.

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Other records listing Halt Medical, 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.

K094009HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI

Related Devices (Code: HFG)

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.

K181124Acessa ProVu SystemAcessa Health, Inc.K101606MICROMED PD-8K INSULATION DEFECT DETECTORMcgan Technology, LLCK991424INSULSCAN INSULATION TESTING SYSTEMMedicor Corp.K961695ENDO-TECH LTD., TIPSRatio Design LabK921405DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIPDavol, Inc.K915406DAVOL ELECTROSUGICAL PROBESDavol, Inc.

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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