FDA 510(k)

SURGI-LINK BIPOLAR ELECTRODES

K-Number: K944898 · 1994-11-01

Decision Date1994-11-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SURGI-LINK BIPOLAR 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 1994-11-01 under 510(k) number K944898. 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 SURGI-LINK BIPOLAR ELECTRODES?

SURGI-LINK BIPOLAR ELECTRODES is a medical device that received FDA 510(k) clearance on 1994-11-01. The listed applicant is Unimed Surgical Products, Inc.. The 510(k) number is K944898.

When did SURGI-LINK BIPOLAR ELECTRODES receive FDA 510(k) clearance?

SURGI-LINK BIPOLAR ELECTRODES received FDA 510(k) clearance on 1994-11-01, under 510(k) number K944898.

Who is the listed applicant for SURGI-LINK BIPOLAR 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 SURGI-LINK BIPOLAR ELECTRODES?

The FDA product code for SURGI-LINK BIPOLAR ELECTRODES is GEI.

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Other records listing Unimed Surgical Products, Inc. as applicant

K132224UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES 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

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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.