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FDA 510(k)

MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES

K-Number: K113597 · 2012-06-03

ApplicantMinilap Technologies
Decision Date2012-06-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Minilap Technologies. It received FDA 510(k) clearance on 2012-06-03 under 510(k) number K113597. 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 MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES?

MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES is a medical device that received FDA 510(k) clearance on 2012-06-03. The listed applicant is Minilap Technologies. The 510(k) number is K113597.

When did MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES receive FDA 510(k) clearance?

MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES received FDA 510(k) clearance on 2012-06-03, under 510(k) number K113597.

Who is the listed applicant for MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES?

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

What is the FDA product code for MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES?

The FDA product code for MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES is GEI.

Related Clinical Trials

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Other records listing Minilap Technologies 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.

K132232MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM

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Official Source

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