TubeClear System— 510(k) K172556

Name: FDA 510(k) clearance K172556
Creator: U.S. Food and Drug Administration
Published: 2018-06-29

Substantially Equivalent

Actuated Medical, Inc.

FDA 510(k) clearance K172556 for TubeClear System, Substantially Equivalent on 2018-06-29. Applicant: Actuated Medical, Inc.. Device class: 2.

Clearance details

Applicant: Actuated Medical, Inc.
Product code: Code KNT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2017-08-24
Decision date: 2018-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellefonte, PA, US

Download summary PDF View on FDA.gov ↗

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K220890 — IO Needle Safety Sheath2022-10-31
K200646 — TubeClear System2020-12-04

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.