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FDA 510(k)

BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS

K-Number: K945995 · 1995-01-31

ApplicantXimed/Prosure/Injectx
Decision Date1995-01-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Ximed/Prosure/Injectx. It received FDA 510(k) clearance on 1995-01-31 under 510(k) number K945995. 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 BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS?

BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1995-01-31. The listed applicant is Ximed/Prosure/Injectx. The 510(k) number is K945995.

When did BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS receive FDA 510(k) clearance?

BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS received FDA 510(k) clearance on 1995-01-31, under 510(k) number K945995.

Who is the listed applicant for BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS?

The FDA 510(k) record lists Ximed/Prosure/Injectx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS?

The FDA product code for BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS is GEI.

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Other records listing Ximed/Prosure/Injectx 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.

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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

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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