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FDA 510(k)

MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010

K-Number: K992714 · 1999-10-05

ApplicantHysterx, Inc.
Decision Date1999-10-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 is the device name listed in this FDA 510(k) record. The listed applicant is Hysterx, Inc.. It received FDA 510(k) clearance on 1999-10-05 under 510(k) number K992714. 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 MONOPOLAR COAGULATOR, MODEL NOS 90001-90010?

MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 is a medical device that received FDA 510(k) clearance on 1999-10-05. The listed applicant is Hysterx, Inc.. The 510(k) number is K992714.

When did MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 receive FDA 510(k) clearance?

MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 received FDA 510(k) clearance on 1999-10-05, under 510(k) number K992714.

Who is the listed applicant for MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010?

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 MONOPOLAR COAGULATOR, MODEL NOS 90001-90010?

The FDA product code for MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010 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 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.

K000911MICROGRASP BIPOLAR COAGULATOR, MODELS 90048-90057K993695LIGA-LOOP SUTURE APPLICATOR

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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