FDA 510(k)

QuikClot Control+ Hemostatic Dressing

K-Number: K220971 · 2022-12-14

Decision Date2022-12-14

Product CodePOD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

QuikClot Control+ Hemostatic Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Z-Medica, LLC. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K220971. The device is classified under product code POD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuikClot Control+ Hemostatic Dressing?

QuikClot Control+ Hemostatic Dressing is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Z-Medica, LLC. The 510(k) number is K220971.

When did QuikClot Control+ Hemostatic Dressing receive FDA 510(k) clearance?

QuikClot Control+ Hemostatic Dressing received FDA 510(k) clearance on 2022-12-14, under 510(k) number K220971.

Who is the listed applicant for QuikClot Control+ Hemostatic Dressing?

The FDA 510(k) record lists Z-Medica, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QuikClot Control+ Hemostatic Dressing?

The FDA product code for QuikClot Control+ Hemostatic Dressing is POD.

Other records listing Z-Medica, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200167QuikClot Control+K181641QuikClot Radial

Related Devices (Code: POD)

K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical K213198Ax-Surgi Surgical HemostatAdvamedica, Inc.K200167QuikClot Control+Z-Medica, LLC K183190NuStatBeeken Biomedical, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.