Quikclot Sport and Quikclot Sport Silver
FDA 510(k) K070010 · Z-Medica Corporation
510(k) numberK070010
Submission
- Device name
- Quikclot Sport and Quikclot Sport Silver
- Applicant
- Z-Medica Corporation
Wallingford, CT, US - Received
- January 3, 2007
- Decision date
- January 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Device class
- Unclassified
To temporarily control bleeding and cover external wounds.
Other 510(k)s with product code QSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20)QSY · Traditional | Lifescience Plus, Inc. | 04/30/2026SE |
| K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…QSY · Traditional | Speciality Fibres and Materials Limited | 02/26/2026SE |
| K250319 | Mfuse (MS001)QSY · Traditional | Machina Medical, Inc. | 12/15/2025SE |
| K253609 | TRAUMAGEL® 2.0 Hemostatic GelQSY · Special | Cresilon, Inc. | 12/12/2025SE |
| K240713 | Traumagel®QSY · Traditional | Cresilon, Inc. | 08/14/2024SE |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)QSY · Traditional | Ushare Medical, Inc. | 05/22/2024SE |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC)QSY · Traditional | Incore Co., Ltd. | 04/19/2024SE |
| K240454 | RESPONDER® Polysaccharide HemostatQSY · Special | Starch Medical, Inc. | 03/15/2024SE |
| K220525 | RESPONDER Polysaccharide HemostatQSY · Traditional | Starch Medical, Inc. | 12/04/2023SE |
| K230589 | Celox Rapid X-Ray GauzeQSY · Traditional | Medtrade Products , Ltd. | 11/17/2023SE |
More from Medtrade Products , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K220971 | QuikClot Control+ Hemostatic DressingPOD · Traditional | 12/14/2022SE |
| 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 |
| K061767 | Quikclot 1ST Response & Quikclot Acs+QSY · Special | 07/19/2006SE |
Questions and answers
When was Quikclot Sport and Quikclot Sport Silver cleared by the FDA?
Quikclot Sport and Quikclot Sport Silver (K070010) received a 510(k) decision of Substantially Equivalent on January 25, 2007, 22 days after the submission was received.
What is the product code of K070010?
The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.