QuikClot Control+ Hemostatic Dressing— 510(k) K220971

Name: FDA 510(k) clearance K220971
Creator: U.S. Food and Drug Administration
Published: 2022-12-14

Substantially Equivalent

Z-Medica, LLC

FDA 510(k) clearance K220971 for QuikClot Control+ Hemostatic Dressing, Substantially Equivalent on 2022-12-14. Applicant: Z-Medica, LLC. Device class: 2.

Clearance details

Applicant: Z-Medica, LLC
Product code: Code POD
Device class: Class 2
Regulation: 21 CFR 878.4454
Advisory panel: General, Plastic Surgery
Date received: 2022-04-04
Decision date: 2022-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code POD

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K243553 — QuikClot Control+ Hemostatic Device2025-03-18
K213198 — Ax-Surgi Surgical Hemostat2023-01-05
K200167 — QuikClot Control+2020-04-23
K183190 — NuStat2019-09-25
DEN160012 — D2 Dressing2017-06-30

More clearances from Z-Medica, LLC

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K181641 — QuikClot Radial2018-12-24
K140757 — D2 HEMOSTANTIC DRESSING2014-07-17
K123387 — QUIKCLOT HEMOSTATIC DRESSING2013-04-12

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