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FDA 510(k)

EXCALIBUR PLUS ELECTROSURGICAL UNIT

K-Number: K953007 · 1995-08-21

ApplicantAspen Laboratories, Inc.
Decision Date1995-08-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXCALIBUR PLUS ELECTROSURGICAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Laboratories, Inc.. It received FDA 510(k) clearance on 1995-08-21 under 510(k) number K953007. 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 EXCALIBUR PLUS ELECTROSURGICAL UNIT?

EXCALIBUR PLUS ELECTROSURGICAL UNIT is a medical device that received FDA 510(k) clearance on 1995-08-21. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K953007.

When did EXCALIBUR PLUS ELECTROSURGICAL UNIT receive FDA 510(k) clearance?

EXCALIBUR PLUS ELECTROSURGICAL UNIT received FDA 510(k) clearance on 1995-08-21, under 510(k) number K953007.

Who is the listed applicant for EXCALIBUR PLUS ELECTROSURGICAL UNIT?

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

What is the FDA product code for EXCALIBUR PLUS ELECTROSURGICAL UNIT?

The FDA product code for EXCALIBUR PLUS ELECTROSURGICAL UNIT is 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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