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FDA 510(k)

BISTAT ELECTROSURGICAL UNIT 60-5400-001

K-Number: K896838 · 1990-02-13

ApplicantAspen Laboratories, Inc.
Decision Date1990-02-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BISTAT ELECTROSURGICAL UNIT 60-5400-001 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 1990-02-13 under 510(k) number K896838. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BISTAT ELECTROSURGICAL UNIT 60-5400-001?

BISTAT ELECTROSURGICAL UNIT 60-5400-001 is a medical device that received FDA 510(k) clearance on 1990-02-13. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K896838.

When did BISTAT ELECTROSURGICAL UNIT 60-5400-001 receive FDA 510(k) clearance?

BISTAT ELECTROSURGICAL UNIT 60-5400-001 received FDA 510(k) clearance on 1990-02-13, under 510(k) number K896838.

Who is the listed applicant for BISTAT ELECTROSURGICAL UNIT 60-5400-001?

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 BISTAT ELECTROSURGICAL UNIT 60-5400-001?

The FDA product code for BISTAT ELECTROSURGICAL UNIT 60-5400-001 is GEX. This falls under the Gastroenterology category.

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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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