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FDA 510(k)

MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057

K-Number: K000911 · 2000-04-14

ApplicantHysterx, Inc.
Decision Date2000-04-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 is the device name listed in this FDA 510(k) record. The listed applicant is Hysterx, Inc.. It received FDA 510(k) clearance on 2000-04-14 under 510(k) number K000911. 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 MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057?

MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Hysterx, Inc.. The 510(k) number is K000911.

When did MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 receive FDA 510(k) clearance?

MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 received FDA 510(k) clearance on 2000-04-14, under 510(k) number K000911.

Who is the listed applicant for MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057?

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

What is the FDA product code for MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057?

The FDA product code for MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057 is GEI.

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Other records listing Hysterx, 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.

K993695LIGA-LOOP SUTURE APPLICATORK992714MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010

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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