WEIGAO EMPTY CARTRIDGE SYRINGE— 510(k) K081241
Substantially EquivalentShandong Weigao Group Medical Polymer Co., Ltd.
FDA 510(k) clearance K081241 for WEIGAO EMPTY CARTRIDGE SYRINGE, Substantially Equivalent on 2008-09-08. Applicant: Shandong Weigao Group Medical Polymer Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shandong Weigao Group Medical Polymer 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
- Shanghai, CN
Recent devices under product code FMF
view allMore clearances from Shandong Weigao Group Medical Polymer Co., Ltd.
view all- K212207 — Sterile Hypodermic Syringe for Single Use
- K212920 — Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
- K102741 — ENTERAL FEEDING BAG AND SETS
- K102328 — BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA
- K072739 — JIERUI SYRINGES AND NEEDLES
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.