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FDA 510(k)

ELECTROSURGICAL UNIT WITH ACCESSORIES

K-Number: K905654 · 1991-03-18

ApplicantAspen Labs
Decision Date1991-03-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL UNIT WITH ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Labs. It received FDA 510(k) clearance on 1991-03-18 under 510(k) number K905654. 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 ELECTROSURGICAL UNIT WITH ACCESSORIES?

ELECTROSURGICAL UNIT WITH ACCESSORIES is a medical device that received FDA 510(k) clearance on 1991-03-18. The listed applicant is Aspen Labs. The 510(k) number is K905654.

When did ELECTROSURGICAL UNIT WITH ACCESSORIES receive FDA 510(k) clearance?

ELECTROSURGICAL UNIT WITH ACCESSORIES received FDA 510(k) clearance on 1991-03-18, under 510(k) number K905654.

Who is the listed applicant for ELECTROSURGICAL UNIT WITH ACCESSORIES?

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 ELECTROSURGICAL UNIT WITH ACCESSORIES?

The FDA product code for ELECTROSURGICAL UNIT WITH ACCESSORIES is GEI.

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 ELECTRODEK904240SINGLE USE LAPARSCOPIC ELECTRODE

Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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