Omnifix Syringe NRFit
FDA 510(k) clearance K241385 · decided 2024-07-13
Clearance details
- K-number
- K241385
- Device name
- Omnifix Syringe NRFit
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-15
- Decision date
- 2024-07-13
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- QEH
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Artiglass NRFitTM Tip L.O.R. Glass Syringes (K213800) | Artiglass Srl | 2022-05-19 |
| NRFit® Caps, Male and Female Neuraxial Tip Caps (K201031) | International Medical Industries, Inc. | 2020-12-16 |
| BD Syringe NRFit Lok and BD Syringe NRFit Slip (K192538) | Becton, Dickinson and Company | 2020-09-04 |
| NRFit Syringe (K181374) | Jiangsu Caina Medical Co.,Ltd | 2018-12-14 |
Recalls involving this device
No recalls on record reference this clearance.