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FDA 510(k)

ELECTRODES/PROBES/DEVICES

K-Number: K974637 · 1998-01-07

ApplicantXimed/Prosure/Injectx
Decision Date1998-01-07
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELECTRODES/PROBES/DEVICES 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 1998-01-07 under 510(k) number K974637. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRODES/PROBES/DEVICES?

ELECTRODES/PROBES/DEVICES is a medical device that received FDA 510(k) clearance on 1998-01-07. The listed applicant is Ximed/Prosure/Injectx. The 510(k) number is K974637.

When did ELECTRODES/PROBES/DEVICES receive FDA 510(k) clearance?

ELECTRODES/PROBES/DEVICES received FDA 510(k) clearance on 1998-01-07, under 510(k) number K974637.

Who is the listed applicant for ELECTRODES/PROBES/DEVICES?

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 ELECTRODES/PROBES/DEVICES?

The FDA product code for ELECTRODES/PROBES/DEVICES is FAS.

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Other records listing Ximed/Prosure/Injectx 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.

K002269ELECTROSURGICAL PROBES AND DEVICES-GELTXK994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESK983765INJECTION NEEDLE PROBE/DEVICE-TUNISK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXK981256ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODEK974484ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE

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Related Devices (Code: FAS)

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.

K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )Dornier Medtech America Inc (Dmta)K250522Multi4 SystemMulti4 Medical ABK240504PLASMA EDGE SystemLamidey Noury MedicalK213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie InnovationK210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbHK210394Electrosurgical accessoryDornier Medtech America, Inc.

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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