TK Insulin Syringe with/without Saftey Retractable Device
FDA 510(k) K191639 · Anhui Tiankang Medical Technology Co., Ltd.
510(k) numberK191639
Submission
- Device name
- TK Insulin Syringe with/without Saftey Retractable Device
- Applicant
- Anhui Tiankang Medical Technology Co., Ltd.
Tianchang, CN - Received
- June 19, 2019
- Decision date
- September 11, 2020
- 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
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| 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 |
|---|---|---|
| K222773 | Feeding TubePIF · Traditional | 08/17/2023SE |
| K222772 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | 08/17/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 08/12/2023SE |
| K222385 | Bifurcated NeedleSCL · Traditional | 12/06/2022SE |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…FMF · Traditional | 07/14/2022SE |
| K212368 | Surgical Face MaskFXX · Traditional | 10/24/2021SE |
| K210464 | Auto Disable SyringeFMF · Traditional | 08/24/2021SE |
| K191640 | TK Intravascular Administration SetFPA · Traditional | 08/26/2020SE |
| K191644 | TK Safety NeedleFMI · Traditional | 08/06/2020SE |
| K191642 | TK Sterile Piston Syringe without NeedleFMF · Traditional | 01/06/2020SE |
Questions and answers
When was TK Insulin Syringe with/without Saftey Retractable Device cleared by the FDA?
TK Insulin Syringe with/without Saftey Retractable Device (K191639) received a 510(k) decision of Substantially Equivalent on September 11, 2020, 450 days after the submission was received.
What is the product code of K191639?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.