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FDA 510(k)

SYSTEM 7500 ABC ELECTROSURGICAL UNIT

K-Number: K981220 · 1998-04-21

ApplicantAspen Laboratories, Inc.
Decision Date1998-04-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYSTEM 7500 ABC 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 1998-04-21 under 510(k) number K981220. 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 SYSTEM 7500 ABC ELECTROSURGICAL UNIT?

SYSTEM 7500 ABC ELECTROSURGICAL UNIT is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Aspen Laboratories, Inc.. The 510(k) number is K981220.

When did SYSTEM 7500 ABC ELECTROSURGICAL UNIT receive FDA 510(k) clearance?

SYSTEM 7500 ABC ELECTROSURGICAL UNIT received FDA 510(k) clearance on 1998-04-21, under 510(k) number K981220.

Who is the listed applicant for SYSTEM 7500 ABC 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 SYSTEM 7500 ABC ELECTROSURGICAL UNIT?

The FDA product code for SYSTEM 7500 ABC ELECTROSURGICAL UNIT is GEI.

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Other records listing Aspen Laboratories, 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.

K963088SHEATH, ELECTROSURGICAL PENCILK955834SYSTEM 6500 ABC ELECTROSURGICAL UNITK9602964000 ETMK953081BEAMER PLUSK953007EXCALIBUR PLUS ELECTROSURGICAL UNITK946104SMOKIEVAC ELECTROSURGICAL PENCIL

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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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