FDA 510(k)

UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE

K-Number: K970066 · 1997-02-18

Decision Date1997-02-18

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Unimed Surgical Products, Inc.. It received FDA 510(k) clearance on 1997-02-18 under 510(k) number K970066. 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 UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE?

UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-02-18. The listed applicant is Unimed Surgical Products, Inc.. The 510(k) number is K970066.

When did UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE receive FDA 510(k) clearance?

UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE received FDA 510(k) clearance on 1997-02-18, under 510(k) number K970066.

Who is the listed applicant for UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE?

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

What is the FDA product code for UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE?

The FDA product code for UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE is GEI.

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Other records listing Unimed Surgical Products, Inc. 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.