ELECTRODES/PROBES/DEVICES— 510(k) K974637

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

1997-12-12

Decision date

1998-01-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

• K251403 — Dornier 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 )2025-12-05
• K250522 — Multi4 System2025-06-27
• K240504 — PLASMA EDGE System2024-06-12
• K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge2022-03-02
• K210651 — Resection Electrodes with HF cable2021-08-03

• 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

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 →