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FDA 510(k)

ACMI BIPOLAR HEMOSTATIC ELECTRODE

K-Number: K803214 · 1981-01-15

ApplicantAmerican Cystocope Makers, Inc.
Decision Date1981-01-15
Product CodeFEH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACMI BIPOLAR HEMOSTATIC ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is American Cystocope Makers, Inc.. It received FDA 510(k) clearance on 1981-01-15 under 510(k) number K803214. The device is classified under product code FEH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACMI BIPOLAR HEMOSTATIC ELECTRODE?

ACMI BIPOLAR HEMOSTATIC ELECTRODE is a medical device that received FDA 510(k) clearance on 1981-01-15. The listed applicant is American Cystocope Makers, Inc.. The 510(k) number is K803214.

When did ACMI BIPOLAR HEMOSTATIC ELECTRODE receive FDA 510(k) clearance?

ACMI BIPOLAR HEMOSTATIC ELECTRODE received FDA 510(k) clearance on 1981-01-15, under 510(k) number K803214.

Who is the listed applicant for ACMI BIPOLAR HEMOSTATIC ELECTRODE?

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

What is the FDA product code for ACMI BIPOLAR HEMOSTATIC ELECTRODE?

The FDA product code for ACMI BIPOLAR HEMOSTATIC ELECTRODE is FEH.

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Other records listing American Cystocope Makers, 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.

K832040STERILE FLUID PRODUCING UNIT #EP550K812637ACMI BIPOLAR HEMOSTATIC SOURCEK811218ACMI ASPIRATOR KIT #8808K791182ACMI RIGI-FLEX NEPHORSCOPEK770754DUODENOSCOPE, MOLEL TX-6K760822MODEL TX-8 PANENDOSCOPE

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Related Devices (Code: FEH)

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.

K130489ELECTRODE, FLEXIBLE SUCTION COAGULATOROptim, LLCK122593PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2Optim, LLC

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.

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