NuStat— 510(k) K183190

Substantially Equivalent

Beeken Biomedical, LLC

FDA 510(k) clearance K183190 for NuStat, Substantially Equivalent on 2019-09-25. Applicant: Beeken Biomedical, LLC. Device class: 2.

Clearance details

Applicant: Beeken Biomedical, LLC
Product code: Code POD
Device class: Class 2
Regulation: 21 CFR 878.4454
Advisory panel: General, Plastic Surgery
Date received: 2018-11-19
Decision date: 2019-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stoughton, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K183190

K-number listed on FDA's recall record

Z-0309-2022 — NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5Class II·Ongoing·Beeken Biomedical, LLC·20211014

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183190.

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