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FDA 510(k)

OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES

K-Number: K981219 · 1998-06-29

ApplicantEnable Medical Corp.
Decision Date1998-06-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES is the device name listed in this FDA 510(k) record. The listed applicant is Enable Medical Corp.. It received FDA 510(k) clearance on 1998-06-29 under 510(k) number K981219. 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 OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES?

OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES is a medical device that received FDA 510(k) clearance on 1998-06-29. The listed applicant is Enable Medical Corp.. The 510(k) number is K981219.

When did OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES receive FDA 510(k) clearance?

OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES received FDA 510(k) clearance on 1998-06-29, under 510(k) number K981219.

Who is the listed applicant for OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES?

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

What is the FDA product code for OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES?

The FDA product code for OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES 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 Enable Medical 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.

K010112BIPOLAR COAGULATION SYSTEMK992996ENABLE ENDOSCOPIC BIPOLAR SCISSORSK972558BIPOLAR SCISSORS

Related Devices (Code: GEI)

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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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