QSZ — Absorbable Synthetic Wound Dressing Class U
Classification Details
- Product Code
- QSZ
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251567 | polynovo biomaterials pty | NovoSorb BTM | June 20, 2025 |
| K242149 | polynovo biomaterials pty | NovoSorb® MTX | March 5, 2025 |
| K241660 | sioxmed | SiOxD® Wound Matrix | July 5, 2024 |
| K232847 | sioxmed | SiOxD Wound Matrix | December 18, 2023 |
| K223725 | acera surgical | Restrata® MiniMatrix | May 18, 2023 |
| K222189 | sioxmed | SiOxD Wound Matrix | November 18, 2022 |
| K221686 | polynovo biomaterials pty | NovoSorb Matrix | September 15, 2022 |
| K193583 | acera surgical | Restrata® | September 25, 2020 |
| K173544 | nanofiber solutions | Phoenix Wound Matrix | March 2, 2018 |
| K172140 | polynovo biomaterials pty | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10c | August 11, 2017 |
| K170213 | polymedics innovations | SupraSDRM Biodegradable Matrix Wound Dressing | June 28, 2017 |
| K170300 | acera surgical | Restrata Wound Matrix | April 26, 2017 |
| K161067 | engineered tissue solutions | Mirragen Advanced Wound Matrix, 4x4, Mirragen Advanced Wound Matrix, 2x2, Mirr | September 15, 2016 |
| K142879 | polynovo biomaterials pty | BTM Wound Dressing | December 23, 2015 |
| K132397 | w.l. gore and associates | GORE BIO-A WOUND MATRIX | May 7, 2014 |
| K090160 | polymedics innovations | SUPRATHEL WOUND AND BURN DRESSING | May 20, 2009 |
| K073251 | fidia advanced biopolymers | HYALOMATRIX PA | December 14, 2007 |
| K031684 | biomet merck | TOPKIN WOUND DRESSING | October 30, 2003 |