FDA 510(k)

UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES

K-Number: K132224 · 2013-10-08

Decision Date2013-10-08

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES 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 2013-10-08 under 510(k) number K132224. 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 SURGICAL COATED ELECTROSURGICAL ELECTRODES?

UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES is a medical device that received FDA 510(k) clearance on 2013-10-08. The listed applicant is Unimed Surgical Products, Inc.. The 510(k) number is K132224.

When did UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES receive FDA 510(k) clearance?

UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES received FDA 510(k) clearance on 2013-10-08, under 510(k) number K132224.

Who is the listed applicant for UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES?

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 SURGICAL COATED ELECTROSURGICAL ELECTRODES?

The FDA product code for UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES is GEI.

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Other records listing Unimed Surgical Products, Inc. as applicant

K993647UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F K970066UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE K963338UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH K962935UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE K944450SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE K944265NEEDLE ELCTRODE

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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.