Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
FDA 510(k) K220057 · Shinva Ande Healthcare Apparatus Co., Ltd.
510(k) numberK220057
Submission
- Device name
- Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
- Applicant
- Shinva Ande Healthcare Apparatus Co., Ltd.
Zibo, CN - Received
- January 6, 2022
- Decision date
- October 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
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|---|---|---|
| K201460 | Closed System Transfer DeviceONB · Traditional | 11/23/2022SE |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle…MEG · Traditional | 03/01/2022SE |
| K202060 | Disposable IV catheterFOZ · Traditional | 07/23/2021SE |
| K193657 | Disposable Enteral Feeding Syringe with Enfit ConnectorPNR · Traditional | 09/12/2020SE |
| K162601 | Infusion Set for Single UseFPA · Traditional | 05/31/2017SE |
Questions and answers
When was Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization cleared by the FDA?
Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization (K220057) received a 510(k) decision of Substantially Equivalent on October 7, 2022, 274 days after the submission was received.
What is the product code of K220057?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.