JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)— 510(k) K103830
Substantially EquivalentJiangsu Shenli Medical Production Factory
FDA 510(k) clearance K103830 for JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK), Substantially Equivalent on 2011-07-29. Applicant: Jiangsu Shenli Medical Production Factory. Device class: 2.
Clearance details
- Applicant
- Jiangsu Shenli Medical Production Factory
- 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
- Abbreviated
- Location
- Mosely, VA, US
Recent devices under product code FMF
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 K103830
K-number listed on FDA's recall record- Z-2940-2024 — McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. 102-S60C - SYRINGE, LL 60CC (25/BX 4BX/CS)
- Z-3033-2024 — Medline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number DYNJSYCPP10R ; 2) SYRINGE CNTRL 10ML YEL L/L LP , Pack Number DYNJSYCPP10Y ; 3) SYRINGE KIT , Pack Number NAM0004; 4) SYR 10ML L/S, Pack Number OEM11623 ; 5) JAPAN 3ML SYRINGE , Pack Number SAMPCJ006; 6) JAPAN 5ML SYRINGE, Pack Number SAMPCJ007; 7) JAPAN 10ML SYRINGE, Pack Number SAMPCJ008; 8) JAPAN 20ML SYRINGE, Pack Number SAMPCJ009; 9) JAPAN 30ML SYRINGE, Pack Number SAMPCJ010; 10) JAPAN 60ML SYRINGE, Pack Number SAMPCJ011
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103830.
Data sourced from openFDA. This site is unofficial and independent of the FDA.