510(k) K240454
- Device
- RESPONDER® Polysaccharide Hemostat
- Applicant
- Starch Medical, Inc.
- 510(k) number
- K240454
- Product code
- QSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-15
- Date received
- 2024-02-15
- Classification name
- Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alice Li
- Address
- 2150 Ringwood Ave. San Jose CA US 95131 95131
FDA Registration Numbers#
- 8043396
- 3003898360
- 2029275
- 3031563325
- 3010256218
- 3012777736
- 3012940386
- 3009317711
- 2244725
- 3032534
- 1423662
- 8021832
- 3007788086
- 3011088743
- 3005761322
- 1625425
- 3007663067
- 3005378067
- 3006260740
- 1047843
- 3015437221
- 1018233
- 3026322855
- 2245304
- 3005460813
- 3006580788
- 3004957256
- 3009756327
- 3007215524
- 3011400126
- 1220477
- 1219313
- 3025413691
- 3007225047
- 3015205402
- 3038718579
- 9611590
- 3002808227
- 3006113097
- 3004111573
- 9612051
- 9617592
- 3010864832
- 9680271
- 3022104448
- 3005853033
- 3001186500
- 3005674475
- 1643817
- 3010123105
- 3034735187
- 1223089
- 3009348684
- 1061124
- 1038758
- 9680091
- 3016844359
- 3027517726
- 3014136088
- 3012888343
- 3006619672
- 3002807310
- 1054811
- 3033589330
- 3011657181
- 1424263
- 1417592
- 1250045
- 3015219237
- 3031288561
- 1066421
- 3008559295
- 3021841055
- 2135339
- 3007735241
- 3015225571
- 3017391151
- 3006082230
- 3023316
- 3027815
Source Documents#
Other 510(k) Records For Product Code QSY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | 2026-04-30 |
| K251700 | 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 | 2026-02-26 |
| K250319 | MFUSE (MS001) | Machina Medical, Inc. | 2025-12-15 |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025-12-12 |
| K240713 | TRAUMAGEL® | Cresilon, Inc. | 2024-08-14 |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. | 2024-05-22 |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | 2024-04-19 |
| K220525 | RESPONDER Polysaccharide Hemostat | Starch Medical, Inc. | 2023-12-04 |
| K230589 | Celox Rapid X-Ray Gauze | Medtrade Products , Ltd. | 2023-11-17 |
| K213413 | Hemostatic Dressing | Jiangsu Newvalue Medical Products Co., Ltd. | 2023-09-01 |
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | 2023-06-28 |
| K223495 | Zeolite Hemostatic Cotton | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2023-05-02 |
| K222909 | Axiostat Gauze | Advamedica, Inc. | 2023-04-07 |
| K210751 | S.E.A.L. Hemostatic Wound Spray | Bc3 Technologies, Inc. | 2023-02-02 |
| K220566 | Vascette HP (hemostatic pad) | Koag, LLC | 2022-07-29 |