510(k) K253747
K253747 is an FDA 510(k) premarket notification submitted by Jiangsu Enjosim Medical Technology Co., Ltd. for the device "Disposable Pen Injector (KXYC-03C02, KXYC-03A03)". The FDA issued a decision of Substantially Equivalent on August 14, 2026. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 2026
- Date Received
- November 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type