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FDA 510(k)

DISPOSABLE PRE-GELLED ELECTROSURGICAL

K-Number: K800557 · 1980-04-21

ApplicantVxtra Corp.
Decision Date1980-04-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE PRE-GELLED ELECTROSURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Vxtra Corp.. It received FDA 510(k) clearance on 1980-04-21 under 510(k) number K800557. 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 DISPOSABLE PRE-GELLED ELECTROSURGICAL?

DISPOSABLE PRE-GELLED ELECTROSURGICAL is a medical device that received FDA 510(k) clearance on 1980-04-21. The listed applicant is Vxtra Corp.. The 510(k) number is K800557.

When did DISPOSABLE PRE-GELLED ELECTROSURGICAL receive FDA 510(k) clearance?

DISPOSABLE PRE-GELLED ELECTROSURGICAL received FDA 510(k) clearance on 1980-04-21, under 510(k) number K800557.

Who is the listed applicant for DISPOSABLE PRE-GELLED ELECTROSURGICAL?

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

What is the FDA product code for DISPOSABLE PRE-GELLED ELECTROSURGICAL?

The FDA product code for DISPOSABLE PRE-GELLED ELECTROSURGICAL is GEI.

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Other records listing Vxtra Corp. as applicant

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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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