Nustat XR
FDA 510(k) K160578 · Beeken Biomedical, LLC
510(k) numberK160578
Submission
- Device name
- Nustat XR
- Applicant
- Beeken Biomedical, LLC
Stoughton, MA, US - Received
- March 1, 2016
- Decision date
- June 29, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
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Questions and answers
When was Nustat XR cleared by the FDA?
Nustat XR (K160578) received a 510(k) decision of Substantially Equivalent on June 29, 2016, 120 days after the submission was received.
What is the product code of K160578?
The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.