DISPOSABLE HEATED WIRE LOOPS 48 AND 72— 510(k) K860941

Substantially Equivalent

Intec Medical, Inc.

FDA 510(k) clearance K860941 for DISPOSABLE HEATED WIRE LOOPS 48 AND 72, Substantially Equivalent on 1986-04-02. Applicant: Intec Medical, Inc..

Clearance details

Applicant: Intec Medical, Inc.
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1986-03-12
Decision date: 1986-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Springs, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.