Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
FDA 510(k) K221247 · Jiangsu Kangbao Medical Equipment Co., Ltd.
510(k) numberK221247
Submission
- Device name
- Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
- Applicant
- Jiangsu Kangbao Medical Equipment Co., Ltd.
Yangzhou, CN - Received
- May 2, 2022
- Decision date
- November 1, 2022
- 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 |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for…MEG · Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. | 10/07/2022SE |
More from Shinva Ande Healthcare Apparatus Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection…JKA · Traditional | 12/22/2023SE |
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | 11/15/2021SE |
| K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type)…FPA · Traditional | 07/28/2020SE |
| K182649 | Enteral Feeding Syringes with Enfit ConnectorsPNR · Traditional | 11/09/2018SE |
Questions and answers
When was Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle cleared by the FDA?
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle (K221247) received a 510(k) decision of Substantially Equivalent on November 1, 2022, 183 days after the submission was received.
What is the product code of K221247?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.