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FDA 510(k)

AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD

K-Number: K972901 · 1997-09-19

ApplicantAmerican Biosurgical, Inc.
Decision Date1997-09-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD is the device name listed in this FDA 510(k) record. The listed applicant is American Biosurgical, Inc.. It received FDA 510(k) clearance on 1997-09-19 under 510(k) number K972901. 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 AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD?

AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD is a medical device that received FDA 510(k) clearance on 1997-09-19. The listed applicant is American Biosurgical, Inc.. The 510(k) number is K972901.

When did AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD receive FDA 510(k) clearance?

AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD received FDA 510(k) clearance on 1997-09-19, under 510(k) number K972901.

Who is the listed applicant for AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD?

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

What is the FDA product code for AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD?

The FDA product code for AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD 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 Biosurgical, 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.

K971540AMERICAN BIOSURGICAL ELECTROSURGICAL MONOPOLAR CABLE/CORDK953889AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD

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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