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FDA 510(k)

ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE

K-Number: K935091 · 1994-02-28

ApplicantConmedcorp
Decision Date1994-02-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Conmedcorp. It received FDA 510(k) clearance on 1994-02-28 under 510(k) number K935091. 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 ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE?

ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE is a medical device that received FDA 510(k) clearance on 1994-02-28. The listed applicant is Conmedcorp. The 510(k) number is K935091.

When did ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE receive FDA 510(k) clearance?

ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE received FDA 510(k) clearance on 1994-02-28, under 510(k) number K935091.

Who is the listed applicant for ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE?

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

What is the FDA product code for ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE?

The FDA product code for ASPEN SURGICAL SYSTEMS COATED BLADE ELECTRODE is GEI.

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Related Devices (Code: GEI)

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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

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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