FDA 510(k)

MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01

K-Number: K100543 · 2010-07-23

Decision Date2010-07-23

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 is the device name listed in this FDA 510(k) record. The listed applicant is Medisiss. It received FDA 510(k) clearance on 2010-07-23 under 510(k) number K100543. 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 MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01?

MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 is a medical device that received FDA 510(k) clearance on 2010-07-23. The listed applicant is Medisiss. The 510(k) number is K100543.

When did MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 receive FDA 510(k) clearance?

MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 received FDA 510(k) clearance on 2010-07-23, under 510(k) number K100543.

Who is the listed applicant for MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01?

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

What is the FDA product code for MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01?

The FDA product code for MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 is GEI.

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Other records listing Medisiss as applicant

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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.