ProSeal Vented Universal Vial Adaptor— 510(k) K240517
Substantially EquivalentEpic Medical Pte. , Ltd.
FDA 510(k) clearance K240517 for ProSeal Vented Universal Vial Adaptor, Substantially Equivalent on 2024-12-26. Applicant: Epic Medical Pte. , Ltd.. Device class: 2.
Clearance details
- Applicant
- Epic Medical Pte. , Ltd.
- Product code
- Code ONB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code ONB
view all- K251722 — ProSeal Transfer Injector (421120, 421130, 421140)
- K253033 — Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor
- K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- K251411 — Chemfort Female Luer Lock Adaptor
- K251340 — ProSeal Bag Spike with Additive Port (423370ST, 423370)
More clearances from Epic Medical Pte. , Ltd.
view allAdverse events under product code ONB
product code ONB- Malfunction
- 3,615
- Other
- 13
- Total
- 3,628
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.