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FDA 510(k)

HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI

K-Number: K094009 · 2010-06-14

ApplicantHalt Medical, Inc.
Decision Date2010-06-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI 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 2010-06-14 under 510(k) number K094009. 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 HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI?

HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI is a medical device that received FDA 510(k) clearance on 2010-06-14. The listed applicant is Halt Medical, Inc.. The 510(k) number is K094009.

When did HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI receive FDA 510(k) clearance?

HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI received FDA 510(k) clearance on 2010-06-14, under 510(k) number K094009.

Who is the listed applicant for HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI?

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 HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI?

The FDA product code for HALT 2000GI ELECTROSURGICAL RF ABLATION SYSTEM MODEL HALT 2000GI is GEI.

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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.

K121858THE ABLATION SYSTEM

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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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