AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
FDA 510(k) clearance K111034 · decided 2011-07-14
Clearance details
- K-number
- K111034
- Device name
- AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
- Applicant
- Am USA
- Decision
- Substantially Equivalent
- Date received
- 2011-04-13
- Decision date
- 2011-07-14
- Days to decision
- 92 days
- Clearance type
- Special
- Product code
- NGT
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Nashville, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Am USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use S recall (Z-2393-2012) | Amsino Medical USA | 2012-09-15 |
| 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use recall (Z-2394-2012) | Amsino Medical USA | 2012-09-15 |