# QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/QSY

## Overview

- **Product Code:** QSY
- **Device Name:** Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Identification

To temporarily control bleeding and cover external wounds.

## Recent Cleared Devices (20 of 127)

Showing 20 most recent of 127 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253017](/device/K253017.md) | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | Apr 30, 2026 | SESE |
| [K251700](/device/K251700.md) | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm  (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm  (FG100701); Ganymede-X 25cm | Speciality Fibres and Materials Limited | Feb 26, 2026 | SESE |
| [K250319](/device/K250319.md) | MFUSE (MS001) | Machina Medical, Inc. | Dec 15, 2025 | SESE |
| [K253609](/device/K253609.md) | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | Dec 12, 2025 | SESE |
| [K240713](/device/K240713.md) | TRAUMAGEL® | Cresilon, Inc. | Aug 14, 2024 | SESE |
| [K240097](/device/K240097.md) | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. | May 22, 2024 | SESE |
| [K232216](/device/K232216.md) | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | Apr 19, 2024 | SESE |
| [K240454](/device/K240454.md) | RESPONDER® Polysaccharide Hemostat | Starch Medical, Inc. | Mar 15, 2024 | SESE |
| [K220525](/device/K220525.md) | RESPONDER Polysaccharide Hemostat | Starch Medical, Inc. | Dec 4, 2023 | SESE |
| [K230589](/device/K230589.md) | Celox Rapid X-Ray Gauze | Medtrade Products , Ltd. | Nov 17, 2023 | SESE |
| [K213413](/device/K213413.md) | Hemostatic Dressing | Jiangsu Newvalue Medical Products Co., Ltd. | Sep 1, 2023 | SESE |
| [K213652](/device/K213652.md) | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | Jun 28, 2023 | SESE |
| [K223495](/device/K223495.md) | Zeolite Hemostatic Cotton | Hangzhou Zeo-Innov Life Technology Co., Ltd. | May 2, 2023 | SESE |
| [K222909](/device/K222909.md) | Axiostat Gauze | Advamedica, Inc. | Apr 7, 2023 | SESE |
| [K210751](/device/K210751.md) | S.E.A.L. Hemostatic Wound Spray | Bc3 Technologies, Inc. | Feb 2, 2023 | SESE |
| [K220566](/device/K220566.md) | Vascette HP (hemostatic pad) | Koag, LLC | Jul 29, 2022 | SESE |
| [K211570](/device/K211570.md) | Zeolite Hemostatic Gauze | Hangzhou Zeo-Innov Life Technology Co., Ltd. | Feb 10, 2022 | SESE |
| [K202830](/device/K202830.md) | Axiostat Patch | Advamedica, Inc. | Apr 15, 2021 | SESE |
| [K192671](/device/K192671.md) | Hemostatic Xerogel Sponge | Solaplus Biotech Co., Ltd. | Aug 28, 2020 | SESE |
| [K190012](/device/K190012.md) | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | Dec 18, 2019 | SESE |

## Top Applicants

- Medtrade Products , Ltd. — 13 clearances
- Hem Con Medical Technologies, Inc. — 9 clearances
- Z-Medica Corporation — 7 clearances
- Hemostasis, LLC — 5 clearances
- Hemcon, Inc. — 4 clearances

---

**Source:** [https://fda.innolitics.com/productcode/QSY](https://fda.innolitics.com/productcode/QSY)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com