MEG · Syringe, Antistick
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | MEG |
|---|---|
| Device Name | Syringe, Antistick |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 163)
Showing 20 most recent of 163 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. | Feb 18, 2026 | SESE |
| K250847 | VaporShield | Vault Paragon Group, Inc. | Dec 12, 2025 | SESE |
| K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | Nov 21, 2023 | SESE |
| K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | Oct 27, 2023 | SESE |
| K231907 | Medline Safety Insulin and TB Syringes | Medline Industries, LP | Oct 18, 2023 | SESE |
| K223376 | 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) | Cardinal Health200, LLC | Jun 21, 2023 | SESE |
| K220114 | PowerPAK Syringe | Vault Paragon Group, Inc. | Jan 25, 2023 | SESE |
| K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | Dec 29, 2022 | SESE |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle) | Shantou Wealy Medical Instrument Co.,Ltd | Nov 23, 2022 | SESE |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle | Jiangsu Kangbao Medical Equipment Co., Ltd. | Nov 1, 2022 | SESE |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization | Shinva Ande Healthcare Apparatus Co., Ltd. | Oct 7, 2022 | SESE |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needles | Sichuan Prius Biotechnology Co., Ltd. | Oct 4, 2022 | SESE |
| K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | Aug 23, 2022 | SESE |
| K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | Aug 18, 2022 | SESE |
| K213077 | Automatically Retractable Safety Syringe | Zhejiang Lingyang Medical Apparatus Co., Ltd. | Apr 27, 2022 | SESE |
| K210216 | Disposable Automatically Retractable Insulin Safety Syringe | Shantou Wealy Medical Instrument Co.,Ltd | Mar 4, 2022 | SESE |
| K212652 | Sterile Syringe with Fixed Safety Needle for Single Use | Gemtier Medical (Shanghai), Inc. | Mar 2, 2022 | SESE |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles | Shinva Ande Healthcare Apparatus Co., Ltd. | Mar 1, 2022 | SESE |
| K212949 | Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use | Henan Nursecare Biotechnology Co., Ltd. | Feb 24, 2022 | SESE |
| K210229 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Zhejiang Kangkang Medical-Devices Co., Ltd. | Feb 15, 2022 | SESE |
Top Applicants
- Safety Syringes, Inc. — 7 clearances
- Life-Shield Products, Inc. — 5 clearances
- M.K. Meditech Co. , Ltd. — 5 clearances
- Biotop Technology Co., Ltd. — 4 clearances
- Retractable Technologies, Inc. — 4 clearances
