Disposable Pen Injector (KXYC-03C02, KXYC-03A03)— 510(k) K253747
Substantially EquivalentJiangsu Enjosim Medical Technology Co., Ltd.
FDA 510(k) clearance K253747 for Disposable Pen Injector (KXYC-03C02, KXYC-03A03), Substantially Equivalent on 2026-08-14. Applicant: Jiangsu Enjosim Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Jiangsu Enjosim Medical Technology Co., Ltd.
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wu Xi, CN
Recent devices under product code FMF
view all- K262581 — GraftGun Universal Graft Delivery System (GDS®)
- K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray
- K260208 — Ultra-Fine SAFETY Insulin Syringe
- K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.