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FDA 510(k)

MULTIFUNCTION ENDOSCOPIC INSTRUMENT

K-Number: K012033 · 2001-09-20

ApplicantSeedling Enterprises., LLC
Decision Date2001-09-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTIFUNCTION ENDOSCOPIC INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Seedling Enterprises., LLC. It received FDA 510(k) clearance on 2001-09-20 under 510(k) number K012033. 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 MULTIFUNCTION ENDOSCOPIC INSTRUMENT?

MULTIFUNCTION ENDOSCOPIC INSTRUMENT is a medical device that received FDA 510(k) clearance on 2001-09-20. The listed applicant is Seedling Enterprises., LLC. The 510(k) number is K012033.

When did MULTIFUNCTION ENDOSCOPIC INSTRUMENT receive FDA 510(k) clearance?

MULTIFUNCTION ENDOSCOPIC INSTRUMENT received FDA 510(k) clearance on 2001-09-20, under 510(k) number K012033.

Who is the listed applicant for MULTIFUNCTION ENDOSCOPIC INSTRUMENT?

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

What is the FDA product code for MULTIFUNCTION ENDOSCOPIC INSTRUMENT?

The FDA product code for MULTIFUNCTION ENDOSCOPIC INSTRUMENT is GEI.

Related Clinical Trials

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Other records listing Seedling Enterprises., LLC 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.

K010710SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODESK002841COOL-TEC ELECTRODESK001723COOL-TEC ELECTRODES

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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