FDA 510(k)

MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM

K-Number: K050364 · 2005-03-09

Decision Date2005-03-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Valley Forge Scientific Corp.. It received FDA 510(k) clearance on 2005-03-09 under 510(k) number K050364. 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 MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM?

MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-09. The listed applicant is Valley Forge Scientific Corp.. The 510(k) number is K050364.

When did MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM receive FDA 510(k) clearance?

MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM received FDA 510(k) clearance on 2005-03-09, under 510(k) number K050364.

Who is the listed applicant for MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM?

The FDA 510(k) record lists Valley Forge Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM?

The FDA product code for MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM is GEI.

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Other records listing Valley Forge Scientific Corp. as applicant

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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.