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FDA 510(k)

Spetzler Malis Dual Illuminating Bipolar Forceps

K-Number: K160103 · 2016-10-12

ApplicantSynergetics
Decision Date2016-10-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Spetzler Malis Dual Illuminating Bipolar Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Synergetics. It received FDA 510(k) clearance on 2016-10-12 under 510(k) number K160103. 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 Spetzler Malis Dual Illuminating Bipolar Forceps?

Spetzler Malis Dual Illuminating Bipolar Forceps is a medical device that received FDA 510(k) clearance on 2016-10-12. The listed applicant is Synergetics. The 510(k) number is K160103.

When did Spetzler Malis Dual Illuminating Bipolar Forceps receive FDA 510(k) clearance?

Spetzler Malis Dual Illuminating Bipolar Forceps received FDA 510(k) clearance on 2016-10-12, under 510(k) number K160103.

Who is the listed applicant for Spetzler Malis Dual Illuminating Bipolar Forceps?

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

What is the FDA product code for Spetzler Malis Dual Illuminating Bipolar Forceps?

The FDA product code for Spetzler Malis Dual Illuminating Bipolar Forceps is GEI.

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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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