TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)— 510(k) K131052

Substantially Equivalent

Actuated Medical, Inc.

FDA 510(k) clearance K131052 for TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS), Substantially Equivalent on 2013-08-16. Applicant: Actuated Medical, Inc..

Clearance details

Applicant: Actuated Medical, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 2013-04-15
Decision date: 2013-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellefonte, PA, 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.