QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Device class

Unclassified

Regulation —

Total clearances

2020-08-28 → 2026-04-30

Last 12 months

Unique sponsors

Definition

What is Hemostatic Wound Dressing Without Thrombin Or Other Biologics

To temporarily control bleeding and cover external wounds.

Classification details

Medical specialty

Unknown

Review panel

Regulation number

—

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Cresilon, Inc.	3	1	2025-12-12
Starch Medical, Inc.	2	0	2024-03-15
Hangzhou Zeo-Innov Life Technology Co., Ltd.	2	0	2023-05-02
Advamedica, Inc.	2	0	2023-04-07
Koag, LLC	1	0	2022-07-29
Speciality Fibres and Materials Limited	1	1	2026-02-26
Lifescience Plus, Inc.	1	1	2026-04-30
Bc3 Technologies, Inc.	1	0	2023-02-02
Jiangsu Newvalue Medical Products Co., Ltd.	1	0	2023-09-01
Medtrade Products , Ltd.	1	0	2023-11-17
Solaplus Biotech Co., Ltd.	1	0	2020-08-28
Machina Medical, Inc.	1	1	2025-12-15
Incore Co., Ltd.	1	0	2024-04-19
Ushare Medical, Inc.	1	0	2024-05-22

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A6000	HCPCS	Non-contact wound warming wound cover for use with the non-contact wound warming device and warming card ✓ CMS-verified description	High	Non-contact wound dressing/hemostatic dressing supply code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-30	K253017	Lifescience Plus, Inc.	BloodSTOP iX Trauma Matrix (TM-iX-20)
2026-02-26	K251700	Speciality Fibres and Materials Limited	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
2025-12-15	K250319	Machina Medical, Inc.	MFUSE (MS001)
2025-12-12	K253609	Cresilon, Inc.	TRAUMAGEL® 2.0 Hemostatic Gel
2024-08-14	K240713	Cresilon, Inc.	TRAUMAGEL®
2024-05-22	K240097	Ushare Medical, Inc.	Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
2024-04-19	K232216	Incore Co., Ltd.	Hemoblock_S (Prescription); Hemoblock_S (OTC)
2024-03-15	K240454	Starch Medical, Inc.	RESPONDER® Polysaccharide Hemostat
2023-12-04	K220525	Starch Medical, Inc.	RESPONDER Polysaccharide Hemostat
2023-11-17	K230589	Medtrade Products , Ltd.	Celox Rapid X-Ray Gauze
2023-09-01	K213413	Jiangsu Newvalue Medical Products Co., Ltd.	Hemostatic Dressing
2023-06-28	K213652	Cresilon, Inc.	Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
2023-05-02	K223495	Hangzhou Zeo-Innov Life Technology Co., Ltd.	Zeolite Hemostatic Cotton
2023-04-07	K222909	Advamedica, Inc.	Axiostat Gauze
2023-02-02	K210751	Bc3 Technologies, Inc.	S.E.A.L. Hemostatic Wound Spray
2022-07-29	K220566	Koag, LLC	Vascette HP (hemostatic pad)
2022-02-10	K211570	Hangzhou Zeo-Innov Life Technology Co., Ltd.	Zeolite Hemostatic Gauze
2021-04-15	K202830	Advamedica, Inc.	Axiostat Patch
2020-08-28	K192671	Solaplus Biotech Co., Ltd.	Hemostatic Xerogel Sponge