510(k) K212949
- Device
- Sterile Syringe With Safety Needle For Single Use, Sterile Syringe With Needle For Single Use, Sterile Syringe For Single Use, Sterile Safety Needle For Single Use, Sterile Needle For Single Use
- Applicant
- Henan Nursecare Biotechnology Co., Ltd
- 510(k) number
- K212949
- Product code
- MEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-24
- Date received
- 2021-09-16
- Regulation
- 880.5860
- Classification name
- Syringe, Antistick
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yaping Zhang
- Address
- Bldg. C1, Xindong Science Park, # 299 Dongzhuo Rd. Xinxiang CN 453700 453700
FDA Registration Numbers#
- 3012050423
- 1423537
- 3036679495
- 3016685880
- 3012777736
- 3008789114
- 3017770710
- 3014456066
- 3011088743
- 3014747754
- 3007392007
- 3007279404
- 1920898
- 3033536319
- 3010085632
- 3010934635
- 3002807968
- 3009746425
- 3003829571
- 3023228837
- 2183771
- 3013513377
- 8040619
- 3002907620
- 3014662855
- 1319639
- 3012116434
- 3007441619
- 3018681450
- 1915484
- 3004458481
- 1423507
- 3029755538
- 3027338968
- 3004417597
- 3009742443
- 3014162214
- 9610847
- 3007594734
- 3017717188
- 1220477
- 3003681915
- 1921846
- 3010515547
- 3014570560
- 3024508819
- 3008307705
- 3034667025
- 3012646696
- 3023339256
- 3038220293
- 3012039263
- 3010864832
- 1450743
- 3022699058
- 3007490412
- 3015142721
- 2243072
- 3020294761
- 3015972753
- 1649518
- 1647137
- 3010405396
- 1213809
- 3030626857
- 3004143450
- 3005246939
- 3006973666
- 3043226252
- 3036722184
- 3013187142
- 3038356900
- 3017509841
- 3004416208
- 3007590959
- 3004425647
- 3037918935
- 3004496829
- 3016904853
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MEG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. | 2026-02-18 |
| K250847 | VaporShield | Vault Paragon Group, Inc. | 2025-12-12 |
| K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | 2023-11-21 |
| K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | 2023-10-27 |
| K231907 | Medline Safety Insulin and TB Syringes | Medline Industries, LP | 2023-10-18 |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) | Cardinal Health200, LLC | 2023-06-21 |
| K220114 | PowerPAK Syringe | Vault Paragon Group, Inc. | 2023-01-25 |
| K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | 2022-12-29 |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | Shantou Wealy Medical Instrument Co.,Ltd | 2022-11-23 |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022-11-01 |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-10-07 |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
| K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | 2022-08-23 |
| K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2022-08-18 |
| K213077 | Automatically Retractable Safety Syringe | Zhejiang Lingyang Medical Apparatus Co., Ltd. | 2022-04-27 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases