EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)— 510(k) K182268

Name: FDA 510(k) clearance K182268
Creator: U.S. Food and Drug Administration
Published: 2019-04-05

Substantially Equivalent

Flat Medical Co., Ltd.

FDA 510(k) clearance K182268 for EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit), Substantially Equivalent on 2019-04-05. Applicant: Flat Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Flat Medical Co., Ltd.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2018-08-21
Decision date: 2019-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMF

view all

K262581 — GraftGun Universal Graft Delivery System (GDS®)2026-08-26
K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray2026-08-25
K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03)2026-08-14
K260208 — Ultra-Fine SAFETY Insulin Syringe2026-07-13
K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe2026-06-18

More clearances from Flat Medical Co., Ltd.

view all

K212615 — EpiFaith CV2022-09-21
K192421 — EpiFaith Syringe2019-09-27

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, 2020-01-01 through 2026-04-23. 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.