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FDA 510(k)

DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM

K-Number: K921716 · 1993-11-08

ApplicantAmerican Surgical Instruments Corp.
Decision Date1993-11-08
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE 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 1993-11-08 under 510(k) number K921716. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM?

DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM is a medical device that received FDA 510(k) clearance on 1993-11-08. The listed applicant is American Surgical Instruments Corp.. The 510(k) number is K921716.

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

DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM received FDA 510(k) clearance on 1993-11-08, under 510(k) number K921716.

Who is the listed applicant for DISPOSABLE 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 DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM?

The FDA product code for DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM is HET.

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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.

K921457IRRIGATION PUMPS AND TUBING AND SUCTION TUBINGK913944NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIESK913999NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBEK911274UNIPOLAR COAGULATOR PROBE SYSTEMK896118NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

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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