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. Device class: 2.
Summary
embecta Medical II's Ultra-Fine SAFETY Insulin Syringe is filed under FMF, piston syringes. The record doesn't give volumes or needle sizes.
Class II, 21 CFR 880.5860. General Hospital is both the classification panel and the review panel. It was a Traditional 510(k).
embecta filed from Parsippany, New Jersey. Review took 171 calendar days (January 23 to July 13, 2026).
Clearance details
- Applicant
- embecta Medical II, LLC
- Product code
- Product 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
- Parsippany, NJ, US
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- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
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.