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FDA 510(k)

ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE

K-Number: K981256 · 1998-05-12

ApplicantXimed/Prosure/Injectx
Decision Date1998-05-12
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE 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 1998-05-12 under 510(k) number K981256. 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 ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE?

ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Ximed/Prosure/Injectx. The 510(k) number is K981256.

When did ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE receive FDA 510(k) clearance?

ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE received FDA 510(k) clearance on 1998-05-12, under 510(k) number K981256.

Who is the listed applicant for ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE?

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 ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE?

The FDA product code for ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE 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 FLEXK974484ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODEK974637ELECTRODES/PROBES/DEVICES

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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.

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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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