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FDA 510(k)

HABIB HEXABLATE

K-Number: K071103 · 2007-06-27

ApplicantEmcision , Ltd.
Decision Date2007-06-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HABIB HEXABLATE is the device name listed in this FDA 510(k) record. The listed applicant is Emcision , Ltd.. It received FDA 510(k) clearance on 2007-06-27 under 510(k) number K071103. 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 HABIB HEXABLATE?

HABIB HEXABLATE is a medical device that received FDA 510(k) clearance on 2007-06-27. The listed applicant is Emcision , Ltd.. The 510(k) number is K071103.

When did HABIB HEXABLATE receive FDA 510(k) clearance?

HABIB HEXABLATE received FDA 510(k) clearance on 2007-06-27, under 510(k) number K071103.

Who is the listed applicant for HABIB HEXABLATE?

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

What is the FDA product code for HABIB HEXABLATE?

The FDA product code for HABIB HEXABLATE is GEI.

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Other records listing Emcision , Ltd. 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.

K180165Habib EndoHPBK161305Habib EUS RFAK083292HABIB ENDOHPBK080717HABIB HEXABLATE 10K073687HABIB LAPAROSCOPIC HEXABLATEK072383HABIB ENDOBLATE

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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.

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