510(k) K212226
K212226 is an FDA 510(k) premarket notification submitted by Zhuhai DR Medical Instruments Co., Ltd. for the device "DR Safety Syringe, Sterile Hypodermic needle for Single use". The FDA issued a decision of Substantially Equivalent on September 29, 2021. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Zhuhai DR Medical Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2021
- Date Received
- July 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Syringe, Antistick
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type