ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE— 510(k) K974484

Name: FDA 510(k) clearance K974484
Creator: U.S. Food and Drug Administration
Published: 1998-02-10

Substantially Equivalent

Ximed/Prosure/Injectx

FDA 510(k) clearance K974484 for ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE, Substantially Equivalent on 1998-02-10. Applicant: Ximed/Prosure/Injectx. Device class: 2.

Clearance details

Applicant: Ximed/Prosure/Injectx
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1997-11-26
Decision date: 1998-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ximed/Prosure/Injectx

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K002269 — ELECTROSURGICAL PROBES AND DEVICES-GELTX2001-01-04
K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES2000-03-01
K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX1998-12-11
K983765 — INJECTION NEEDLE PROBE/DEVICE-TUNIS1998-12-11
K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE1998-05-12

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.