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FDA 510(k)

ELECTROSURGICAL PROBES AND DEVICES-GELTX

K-Number: K002269 · 2001-01-04

ApplicantXimed/Prosure/Injectx
Decision Date2001-01-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELECTROSURGICAL PROBES AND DEVICES-GELTX is the device name listed in this FDA 510(k) record. The listed applicant is Ximed/Prosure/Injectx. It received FDA 510(k) clearance on 2001-01-04 under 510(k) number K002269. 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 PROBES AND DEVICES-GELTX?

ELECTROSURGICAL PROBES AND DEVICES-GELTX is a medical device that received FDA 510(k) clearance on 2001-01-04. The listed applicant is Ximed/Prosure/Injectx. The 510(k) number is K002269.

When did ELECTROSURGICAL PROBES AND DEVICES-GELTX receive FDA 510(k) clearance?

ELECTROSURGICAL PROBES AND DEVICES-GELTX received FDA 510(k) clearance on 2001-01-04, under 510(k) number K002269.

Who is the listed applicant for ELECTROSURGICAL PROBES AND DEVICES-GELTX?

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

What is the FDA product code for ELECTROSURGICAL PROBES AND DEVICES-GELTX?

The FDA product code for ELECTROSURGICAL PROBES AND DEVICES-GELTX is GEI.

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Other records listing Ximed/Prosure/Injectx as applicant

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K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXK983765INJECTION NEEDLE PROBE/DEVICE-TUNISK981256ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODEK974484ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODEK974637ELECTRODES/PROBES/DEVICES

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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

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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