ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE— 510(k) K981256

Clearance details

Applicant

Ximed/Prosure/Injectx

Product code

Code FAS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

1998-04-02

Decision date

1998-05-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

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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
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Death

3

Injury

344

Malfunction

1,130

Total

1,477

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 →