510(k) K221247
K221247 is an FDA 510(k) premarket notification submitted by Jiangsu Kangbao Medical Equipment Co., Ltd. for the device "Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle". The FDA issued a decision of Substantially Equivalent on November 1, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jiangsu Kangbao Medical Equipment Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2022
- Date Received
- May 2, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Antistick
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type