QuikClot Control+ Hemostatic Device
FDA 510(k) K243553 · Teleflex Medical
510(k) numberK243553
Submission
- Device name
- QuikClot Control+ Hemostatic Device
- Applicant
- Teleflex Medical
Morrisville, NC, US - Received
- November 18, 2024
- Decision date
- March 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- POD – Temporary, Internal Use Hemostatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4454
- Specialty
- General, Plastic Surgery
- Life-sustaining
- Yes
Intended to control severely bleeding wounds
Other 510(k)s with product code POD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213198 | Ax-Surgi Surgical HemostatPOD · Traditional | Advamedica, Inc. | 01/05/2023SE |
| K220971 | QuikClot Control+ Hemostatic DressingPOD · Traditional | Z-Medica, LLC | 12/14/2022SE |
| K200167 | QuikClot Control+POD · Traditional | Z-Medica, LLC | 04/23/2020SE |
| K183190 | NuStatPOD · Traditional | Beeken Biomedical, LLC | 09/25/2019SE |
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Questions and answers
When was QuikClot Control+ Hemostatic Device cleared by the FDA?
QuikClot Control+ Hemostatic Device (K243553) received a 510(k) decision of Substantially Equivalent on March 18, 2025, 120 days after the submission was received.
What is the product code of K243553?
The FDA product code is POD – Temporary, Internal Use Hemostatic, a Class II (moderate risk) device regulated under 21 CFR 878.4454.