QuikClot Control+ Hemostatic Dressing
FDA 510(k) K220971 · Z-Medica, LLC
510(k) numberK220971
Submission
- Device name
- QuikClot Control+ Hemostatic Dressing
- Applicant
- Z-Medica, LLC
Wallingford, CT, US - Received
- April 4, 2022
- Decision date
- December 14, 2022
- 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 |
|---|---|---|---|
| K243553 | QuikClot Control+ Hemostatic DevicePOD · Traditional | Teleflex Medical | 03/18/2025SE |
| K213198 | Ax-Surgi Surgical HemostatPOD · Traditional | Advamedica, Inc. | 01/05/2023SE |
| K200167 | QuikClot Control+POD · Traditional | Z-Medica, LLC | 04/23/2020SE |
| K183190 | NuStatPOD · Traditional | Beeken Biomedical, LLC | 09/25/2019SE |
More from Beeken Biomedical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K200167 | QuikClot Control+POD · Traditional | 04/23/2020SE |
| K181641 | QuikClot RadialQSY · Traditional | 12/24/2018SE |
| K140757 | D2 Hemostantic DressingQSY · Traditional | 07/17/2014SE |
| K123387 | Quikclot Hemostatic DressingQSY · Traditional | 04/12/2013SE |
| K120782 | Interventional Hemostatic BandageQSY · Traditional | 03/20/2013SE |
| K090620 | Quikclot Inteventional, Model P/N 182QSY · Traditional | 04/08/2009SE |
| K080247 | Quikclot NosebleedLYA · Traditional | 02/27/2008SE |
| K072474 | Quikclot ExQSY · Traditional | 10/16/2007SE |
| K070010 | Quikclot Sport and Quikclot Sport SilverQSY · Special | 01/25/2007SE |
| K061767 | Quikclot 1ST Response & Quikclot Acs+QSY · Special | 07/19/2006SE |
Questions and answers
When was QuikClot Control+ Hemostatic Dressing cleared by the FDA?
QuikClot Control+ Hemostatic Dressing (K220971) received a 510(k) decision of Substantially Equivalent on December 14, 2022, 254 days after the submission was received.
What is the product code of K220971?
The FDA product code is POD – Temporary, Internal Use Hemostatic, a Class II (moderate risk) device regulated under 21 CFR 878.4454.