Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
FDA 510(k) K190183 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
510(k) numberK190183
Submission
- Device name
- Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Taihu, Anqing City, CN - Received
- February 1, 2019
- Decision date
- October 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEG – Syringe, Antistick
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code MEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)MEG · Traditional | Methyl Co., Ltd. | 02/18/2026SE |
| K250847 | VaporShieldMEG · Traditional | Vault Paragon Group, Inc. | 12/12/2025SE |
| K230287 | SaviSafe Safety DeviceMEG · Traditional | Suzhou Savicred Biotechnology Co., Ltd. | 11/21/2023SE |
| K231165 | Shina Syringe; Shina Safety SyringeMEG · Traditional | Shina Med Corporation | 10/27/2023SE |
| K231907 | Medline Safety Insulin and TB SyringesMEG · Traditional | Medline Industries, LP | 10/18/2023SE |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated | Cardinal Health200, LLC | 06/21/2023SE |
| K220114 | PowerPAK SyringeMEG · Traditional | Vault Paragon Group, Inc. | 01/25/2023SE |
| K221981 | SafeR Syringe and SafeR StingMEG · Traditional | Roncadelle Operations Srl | 12/29/2022SE |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 11/23/2022SE |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 11/01/2022SE |
More from Jiangsu Kangbao Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K234024 | HWJECT Auto-disable syringeFMF · Traditional | 03/19/2024SE |
| K230061 | Insulin SyringeFMF · Traditional | 11/30/2023SE |
| K230043 | Insulin Pen NeedleFMI · Traditional | 09/20/2023SE |
| K223323 | Blood Collection Needle (with/without Needle Holder)JKA · Traditional | 03/24/2023SE |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleFMI · Traditional | 11/04/2022SE |
| K222141 | Safety Blood Collection Needle (Without Needle Holder)JKA · Traditional | 10/21/2022SE |
| K220900 | Safety Blood Collection Needles with/without Needle HolderJKA · Traditional | 08/10/2022SE |
| K220083 | LDV((Low Dead Volume )SyringeQNQ · Traditional | 05/25/2022SE |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…FMI · Traditional | 04/12/2022SE |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEG · Traditional | 10/18/2021SE |
Questions and answers
When was Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe cleared by the FDA?
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe (K190183) received a 510(k) decision of Substantially Equivalent on October 4, 2019, 245 days after the submission was received.
What is the product code of K190183?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.