510(k) K241385
- Device
- Omnifix Syringe NRFit
- Applicant
- B.Braun Medical, Inc.
- 510(k) number
- K241385
- Product code
- QEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-13
- Date received
- 2024-05-15
- Regulation
- 880.5860
- Classification name
- Piston Syringe With Neuraxial Connector ? Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Smith Kimberly
- Address
- 824 Twelfth Ave. Bethlehem PA US 18018 18018
FDA Registration Numbers#
- 1213809
- 1018470
- 3013764800
- 8031007
- 2243072
- 1920898
- 8010674
- 3005670221
- 9680615
- 3017509841
- 1911916
- 1217831
- 9610825
- 1423507
- 1061927
Source Documents#
Other 510(k) Records For Product Code QEH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213800 | Artiglass NRFitTM Tip L.O.R. Glass Syringes | Artiglass Srl | 2022-05-19 |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | International Medical Industries, Inc. | 2020-12-16 |
| K192538 | BD Syringe NRFit Lok and BD Syringe NRFit Slip | Becton, Dickinson and Company | 2020-09-04 |
| K181374 | NRFit Syringe | Jiangsu Caina Medical Co.,Ltd | 2018-12-14 |