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FDA 510(k)

QuikClot Control+ Hemostatic Device

K-Number: K243553 · 2025-03-18

ApplicantTeleflex Medical
Decision Date2025-03-18
Product CodePOD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QuikClot Control+ Hemostatic Device is a medical device manufactured by Teleflex Medical. It received FDA 510(k) clearance on 2025-03-18 under approval number K243553. 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 Device?

QuikClot Control+ Hemostatic Device is a medical device that received FDA 510(k) clearance on 2025-03-18. It is manufactured by Teleflex Medical. The 510(k) number is K243553.

When was QuikClot Control+ Hemostatic Device approved by the FDA?

QuikClot Control+ Hemostatic Device received FDA 510(k) clearance on 2025-03-18, under approval number K243553.

What company makes QuikClot Control+ Hemostatic Device?

QuikClot Control+ Hemostatic Device is manufactured by Teleflex Medical.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 42105288 Evaluating regulatory oversight through major Expert review of medical devices (2026) PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

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Related Devices (Code: POD)

DEN160012D2 DressingZ-Medica, LLC K183190NuStatBeeken Biomedical, LLC K200167QuikClot Control+Z-Medica, LLC K220971QuikClot Control+ Hemostatic DressingZ-Medica, LLC K213198Ax-Surgi Surgical HemostatAdvamedica, Inc.

Official Source

View on FDA Database →

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

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