510(k) K231792
- Device
- VeriSafe Safety sterile syringes
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- 510(k) number
- K231792
- Product code
- FMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-28
- Date received
- 2023-06-20
- Regulation
- 880.5860
- Classification name
- Syringe, Piston
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Zearou Yang
- Address
- # 1388 Cangxing St. Cangqian Community, Yuhang District Hangzhou City CN 311121 311121
FDA Registration Numbers#
- 3043022296
- 3016851379
- 3008496303
- 3030446844
- 3012552122
- 3010400367
- 3008114965
- 3005064037
- 3002497459
- 9611516
- 2022435
- 3003589279
- 2649614
- 3004756837
- 3042971905
- 1911916
- 1643817
- 3009742443
- 3036722184
- 3015474594
- 3002807090
- 1018120
- 9680794
- 9613304
- 3013221738
- 2025870
- 3014262693
- 3020460367
- 3012478173
- 8043792
- 3005609751
- 3006846316
- 3021226419
- 1000113657
- 8010026
- 1518293
- 9612152
- 1058602
- 2183744
- 3012798826
- 3012809732
- 3012448339
- 2320767
- 3010331645
- 1047843
- 3000268902
- 3017208642
- 3011270181
- 1450743
- 9610993
- 3027339877
- 1320894
- 9680615
- 3005813632
- 3015309643
- 8040619
- 3031983053
- 3007193283
- 3030201489
- 1066491
- 9616679
- 1213809
- 3003529145
- 3008650117
- 2249915
- 3033589330
- 3024508819
- 3043709866
- 8010418
- 3012421607
- 3009595577
- 3021393544
- 1423537
- 2244771
- 3013680140
- 3006380458
- 2243072
- 1724474
- 2530154
Source Documents#
Other 510(k) Records For Product Code FMF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | 2026-08-26 |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | 2026-08-25 |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2026-08-14 |
| K260208 | Ultra-Fine™ SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026-06-18 |
| K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | 2026-06-12 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 |
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 |