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FDA 510(k)

UNIPOLAR COAGULATOR PROBE SYSTEM

K-Number: K911274 · 1991-06-20

ApplicantAmerican Surgical Instruments Corp.
Decision Date1991-06-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UNIPOLAR COAGULATOR PROBE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Surgical Instruments Corp.. It received FDA 510(k) clearance on 1991-06-20 under 510(k) number K911274. 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 UNIPOLAR COAGULATOR PROBE SYSTEM?

UNIPOLAR COAGULATOR PROBE SYSTEM is a medical device that received FDA 510(k) clearance on 1991-06-20. The listed applicant is American Surgical Instruments Corp.. The 510(k) number is K911274.

When did UNIPOLAR COAGULATOR PROBE SYSTEM receive FDA 510(k) clearance?

UNIPOLAR COAGULATOR PROBE SYSTEM received FDA 510(k) clearance on 1991-06-20, under 510(k) number K911274.

Who is the listed applicant for UNIPOLAR COAGULATOR PROBE SYSTEM?

The FDA 510(k) record lists American Surgical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIPOLAR COAGULATOR PROBE SYSTEM?

The FDA product code for UNIPOLAR COAGULATOR PROBE SYSTEM is GEI.

Related Clinical Trials

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.

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Other records listing American Surgical Instruments Corp. 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.

K921716DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEMK921457IRRIGATION PUMPS AND TUBING AND SUCTION TUBINGK913944NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIESK913999NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBEK896118NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE

Related Devices (Code: GEI)

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.

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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.

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