Ultra-Fine SAFETY Insulin Syringe— 510(k) K260208
Substantially Equivalentembecta Medical II, LLC
FDA 510(k) clearance K260208 for Ultra-Fine SAFETY Insulin Syringe, Substantially Equivalent on 2026-07-13. Applicant: embecta Medical II, LLC.
Clearance details
- Applicant
- embecta Medical II, LLC
- Product code
- Code FMF
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parsippany, NJ, US
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.