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.
Summary
Jiangsu Enjosim Medical Technology filed a Disposable Pen Injector in two models, KXYC-03C02 and KXYC-03A03, under product code FMF, piston syringes.
Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel, and the submission type is Traditional.
Enjosim filed from Wu Xi, China. The decision came 262 calendar days after receipt (November 25, 2025 to August 14, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Jiangsu Enjosim Medical Technology Co., Ltd.
- Product code
- Product 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.