Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
FDA 510(k) clearance K211329 · decided 2021-11-15
Clearance details
- K-number
- K211329
- Device name
- Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
- Applicant
- Jiangsu Kangbao Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-05-03
- Decision date
- 2021-11-15
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Yangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (K252098) | Methyl Co., Ltd. | 2026-02-18 |
| VaporShield (K250847) | Vault Paragon Group, Inc. | 2025-12-12 |
| SaviSafe Safety Device (K230287) | Suzhou Savicred Biotechnology Co., Ltd. | 2023-11-21 |
| Shina Syringe; Shina Safety Syringe (K231165) | Shina Med Corporation | 2023-10-27 |
| Medline Safety Insulin and TB Syringes (K231907) | Medline Industries, LP | 2023-10-18 |
| 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) (K223376) | Cardinal Health200, LLC | 2023-06-21 |
| PowerPAK Syringe (K220114) | Vault Paragon Group, Inc. | 2023-01-25 |
| SafeR Syringe and SafeR Sting (K221981) | Roncadelle Operations Srl | 2022-12-29 |
| Disposable Automatically Retractable Safety Syringes (with detachable needle) (K222452) | Shantou Wealy Medical Instrument Co.,Ltd | 2022-11-23 |
| Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle (K221247) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022-11-01 |
| Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization (K220057) | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-10-07 |
| Sterile Hypodermic Syringes for Single Use with Safety Needles (K221073) | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 |
Recalls involving this device
No recalls on record reference this clearance.