FDA 510(k)

DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE

K-Number: K945893 · 1994-12-13

Decision Date1994-12-13

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Surgical Products, Inc.. It received FDA 510(k) clearance on 1994-12-13 under 510(k) number K945893. 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 DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE?

DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-12-13. The listed applicant is Boston Surgical Products, Inc.. The 510(k) number is K945893.

When did DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE receive FDA 510(k) clearance?

DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE received FDA 510(k) clearance on 1994-12-13, under 510(k) number K945893.

Who is the listed applicant for DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE?

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

What is the FDA product code for DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE?

The FDA product code for DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE is GEI.

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Other records listing Boston 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.