BIPOLAR CARD— 510(k) K831236

Name: FDA 510(k) clearance K831236
Creator: U.S. Food and Drug Administration
Published: 1983-06-02

Substantially Equivalent

New England Surgical Instrument Corp.

FDA 510(k) clearance K831236 for BIPOLAR CARD, Substantially Equivalent on 1983-06-02. Applicant: New England Surgical Instrument Corp.. Device class: 2.

Clearance details

Applicant: New England Surgical Instrument Corp.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1983-04-15
Decision date: 1983-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K883396 — HANDSWITCHING MONOPOLAR PENCIL1988-09-13
K880863 — BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-12001988-04-19

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.