FOAM HELMET - USE W/ESOPHAGEAL TAMPONA— 510(k) K832859

Substantially Equivalent

Inmed Corp.

FDA 510(k) clearance K832859 for FOAM HELMET - USE W/ESOPHAGEAL TAMPONA, Substantially Equivalent on 1983-11-14. Applicant: Inmed Corp..

Clearance details

Applicant: Inmed Corp.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1983-08-23
Decision date: 1983-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.