PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE— 510(k) K870977

Name: FDA 510(k) clearance K870977
Creator: U.S. Food and Drug Administration
Published: 1987-04-01

Substantially Equivalent

American Pharmaseal Div. Ahsc

FDA 510(k) clearance K870977 for PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE, Substantially Equivalent on 1987-04-01. Applicant: American Pharmaseal Div. Ahsc. Device class: 2.

Clearance details

Applicant: American Pharmaseal Div. Ahsc
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1987-03-10
Decision date: 1987-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.