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FDA 510(k)

SINGLE USE LAPARSCOPIC ELECTRODE

K-Number: K904240 · 1991-02-19

ApplicantAspen Labs
Decision Date1991-02-19
Product CodeHFG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SINGLE USE LAPARSCOPIC ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Labs. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K904240. The device is classified under product code HFG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE USE LAPARSCOPIC ELECTRODE?

SINGLE USE LAPARSCOPIC ELECTRODE is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Aspen Labs. The 510(k) number is K904240.

When did SINGLE USE LAPARSCOPIC ELECTRODE receive FDA 510(k) clearance?

SINGLE USE LAPARSCOPIC ELECTRODE received FDA 510(k) clearance on 1991-02-19, under 510(k) number K904240.

Who is the listed applicant for SINGLE USE LAPARSCOPIC ELECTRODE?

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

What is the FDA product code for SINGLE USE LAPARSCOPIC ELECTRODE?

The FDA product code for SINGLE USE LAPARSCOPIC ELECTRODE is HFG.

Related Clinical Trials

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Other records listing Aspen Labs 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.

K970493HYFRECATOR 2000K925333SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODEK931215HAND-TROL SK912046SINGLE USE LEE ELECTRODEK905654ELECTROSURGICAL UNIT WITH ACCESSORIES

Related Devices (Code: HFG)

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.

K181124Acessa ProVu SystemAcessa Health, Inc.K121858THE ABLATION SYSTEMHalt Medical, Inc.K101606MICROMED PD-8K INSULATION DEFECT DETECTORMcgan Technology, LLCK991424INSULSCAN INSULATION TESTING SYSTEMMedicor Corp.K961695ENDO-TECH LTD., TIPSRatio Design LabK921405DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIPDavol, Inc.

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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