FDA 510(k)

SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE

K-Number: K944450 · 1995-07-25

Decision Date1995-07-25

Product CodeHGI

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP 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 1995-07-25 under 510(k) number K944450. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE?

SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-07-25. The listed applicant is Unimed Surgical Products, Inc.. The 510(k) number is K944450.

When did SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE receive FDA 510(k) clearance?

SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE received FDA 510(k) clearance on 1995-07-25, under 510(k) number K944450.

Who is the listed applicant for SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP 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 SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE?

The FDA product code for SURGI-LINK LLETZ NEEDLE ELECTRODE, LOOP ELECTRODE, SQUARE LOOP ELECTRODE is HGI.

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Other records listing Unimed Surgical Products, Inc. as applicant

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Related Devices (Code: HGI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.