OR TUBE RESTRAINT— 510(k) K851874

Substantially Equivalent

Kinetic Concepts, Inc.

FDA 510(k) clearance K851874 for OR TUBE RESTRAINT, Substantially Equivalent on 1985-08-08. Applicant: Kinetic Concepts, Inc..

Clearance details

Applicant: Kinetic Concepts, Inc.
Product code: Code CBH
Advisory panel: Anesthesiology
Date received: 1985-04-29
Decision date: 1985-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBH

product code CBH

Death: 7
Total: 7

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.