Sterile Hypodermic Syringe for Single Use— 510(k) K212207
Substantially EquivalentShandong Weigao Group Medical Polymer Co., Ltd.
FDA 510(k) clearance K212207 for Sterile Hypodermic Syringe for Single Use, Substantially Equivalent on 2023-03-23. 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
- Weihai, CN
Recent devices under product code FMF
view allMore clearances from Shandong Weigao Group Medical Polymer Co., Ltd.
view all- 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
- K081241 — WEIGAO EMPTY CARTRIDGE SYRINGE
- 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.