FDA 510(k)

600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE

K-Number: K885200 · 1989-01-13

Decision Date1989-01-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Electrosurgical, Inc.. It received FDA 510(k) clearance on 1989-01-13 under 510(k) number K885200. 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 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE?

600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE is a medical device that received FDA 510(k) clearance on 1989-01-13. The listed applicant is Olsen Electrosurgical, Inc.. The 510(k) number is K885200.

When did 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE receive FDA 510(k) clearance?

600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE received FDA 510(k) clearance on 1989-01-13, under 510(k) number K885200.

Who is the listed applicant for 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE?

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

What is the FDA product code for 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE?

The FDA product code for 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE is GEI.

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Other records listing Olsen Electrosurgical, Inc. as applicant

K922154INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION K912611OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USE K913108TEFLON COATED ELECTRODES/ELECTRODES HANDLES K912612SMOKE/ODOR EVACUATOR #757 K885199#500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES K884171#875 DISPOSABLE BIOPOLAR CABLE

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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.