510(k) K221416
- Device
- Sterile Safety Syringes For Single Use
- Applicant
- Shanghai Kindly Enterprise Development Group Co., Ltd
- 510(k) number
- K221416
- Product code
- MEG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-31
- Date received
- 2022-05-16
- Regulation
- 880.5860
- Classification name
- Syringe, Antistick
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Clearance type
- Traditional
- Third party reviewed
- No
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#
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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