DISPOSABLE BIPOLAR ELECTRODE— 510(k) K952832

Name: FDA 510(k) clearance K952832
Creator: U.S. Food and Drug Administration
Published: 1995-07-26

Substantially Equivalent

Neuro Navigational Corp.

FDA 510(k) clearance K952832 for DISPOSABLE BIPOLAR ELECTRODE, Substantially Equivalent on 1995-07-26. Applicant: Neuro Navigational Corp.. Device class: 2.

Clearance details

Applicant: Neuro Navigational Corp.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1995-06-20
Decision date: 1995-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

view all

K254185 — Potenza Prime2026-09-11
K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

More clearances from Neuro Navigational Corp.

view all

K965078 — 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS1997-03-06
K961406 — NEUROVIEW SCISSORS1996-06-13
K961173 — 1.2MM REUSABLE NEUROVIEW ENDOSCOPE1996-06-07
K961300 — ASPIRATION/IRRIGATION CATHETER1996-06-07
K960792 — DISPOSABLE NEUROVIEW INTRODUCER SHEATH1996-04-11

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.