SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
FDA 510(k) clearance K101270 · decided 2011-02-10
Clearance details
- K-number
- K101270
- Device name
- SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
- Applicant
- Excelsior Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-06
- Decision date
- 2011-02-10
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Dundas, On, CA
- Third-party review
- No
- Expedited review
- No
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| Praxiject™ 0.9% NaCl (K231754) | Medxl, Inc. | 2023-07-13 |
| Pentaflush (K214080) | Pentaferte Italia S.R.L. | 2022-07-20 |
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| 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch (K201286) | Nurse Assist, LLC | 2020-08-11 |
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Recalls involving this device
No recalls on record reference this clearance.