510(k) K220057
K220057 is an FDA 510(k) premarket notification submitted by Shinva Ande Healthcare Apparatus Co., Ltd. for the device "Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization". The FDA issued a decision of Substantially Equivalent on October 7, 2022. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Shinva Ande Healthcare Apparatus Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2022
- Date Received
- January 6, 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