Intraosseous Cannula System Bio-MAC¿ and Bio-CORE— 510(k) K141910

Name: FDA 510(k) clearance K141910
Creator: U.S. Food and Drug Administration
Published: 2015-05-04

Substantially Equivalent

Biologic Therapies, Inc.

FDA 510(k) clearance K141910 for Intraosseous Cannula System Bio-MAC¿ and Bio-CORE, Substantially Equivalent on 2015-05-04. Applicant: Biologic Therapies, Inc.. Device class: 2.

Clearance details

Applicant: Biologic Therapies, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2014-07-15
Decision date: 2015-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Prior Lake, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

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Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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 →

Recalls naming K141910

K-number listed on FDA's recall record

Z-1373-2015 — Bio-MAC Cannula (Needle) SetClass II·Terminated·Biologic Therapies, Inc·20150123
Z-1374-2015 — Bio-CORE Cannula (Needle) SetClass II·Terminated·Biologic Therapies, Inc·20150123

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141910.

Data sourced from openFDA. This site is unofficial and independent of the FDA.