YI XIN STERILE SYRINGE FOR SINGLE USE— 510(k) K050999
Substantially EquivalentJiangxi Sanxin (Eversincere) Medical Devices Group
FDA 510(k) clearance K050999 for YI XIN STERILE SYRINGE FOR SINGLE USE, Substantially Equivalent on 2005-09-02. Applicant: Jiangxi Sanxin (Eversincere) Medical Devices Group. Device class: 2.
Clearance details
- Applicant
- Jiangxi Sanxin (Eversincere) Medical Devices Group
- 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
- Nanchang, Jiangxi, CN
Recent devices under product code FMF
view allMore clearances from Jiangxi Sanxin (Eversincere) Medical Devices Group
view allAdverse 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 →
Recalls naming K050999
K-number listed on FDA's recall record- Z-0005-2024 — 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
- Z-0006-2024 — 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
- Z-0007-2024 — 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050999.
Data sourced from openFDA. This site is unofficial and independent of the FDA.