Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use— 510(k) K201284
Substantially EquivalentSet Medikal Sanayi VE Ticaret Anonim Sirketi
FDA 510(k) clearance K201284 for Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use, Substantially Equivalent on 2020-12-14. Applicant: Set Medikal Sanayi VE Ticaret Anonim Sirketi. Device class: 2.
Clearance details
- Applicant
- Set Medikal Sanayi VE Ticaret Anonim Sirketi
- 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
- Istanbul, TR
Recent devices under product code FMF
view allMore clearances from Set Medikal Sanayi VE Ticaret Anonim Sirketi
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.