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FDA 510(k)

MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD

K-Number: K912780 · 1991-12-30

ApplicantElectroscope, Inc.
Decision Date1991-12-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Electroscope, Inc.. It received FDA 510(k) clearance on 1991-12-30 under 510(k) number K912780. 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 MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD?

MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD is a medical device that received FDA 510(k) clearance on 1991-12-30. The listed applicant is Electroscope, Inc.. The 510(k) number is K912780.

When did MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD receive FDA 510(k) clearance?

MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD received FDA 510(k) clearance on 1991-12-30, under 510(k) number K912780.

Who is the listed applicant for MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD?

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

What is the FDA product code for MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD?

The FDA product code for MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD is GEI.

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Other records listing Electroscope, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000480ACTIVE ELECTRODE MONITORING SYSTEMK972562BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLEDK973682BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,K913625ELECTROSCOPE MONITOR, EM-1K912781ELECTROSHIELD

Related Devices (Code: GEI)

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Official Source

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