AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE— 510(k) K111034
Substantially EquivalentAm USA
FDA 510(k) clearance K111034 for AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE, Substantially Equivalent on 2011-07-14. Applicant: Am USA. Device class: 2.
Clearance details
- Applicant
- Am USA
- Product code
- Code NGT
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Nashville, TN, US
Recent devices under product code NGT
view all- K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
- K233623 — Praxiject SP 0.9% NaCl
- K231724 — Flush Syringe (Prefilled 0.9% normal saline solution)
- K231363 — Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
- K223584 — Pre-Filled Normal Saline Flush Syringe
More clearances from Am USA
view allAdverse events under product code NGT
product code NGT- Death
- 12
- Malfunction
- 2,008
- Other
- 4
- Total
- 2,024
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 →
Recalls naming K111034
K-number listed on FDA's recall record- Z-2393-2012 — 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
- Z-2394-2012 — 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111034.
Data sourced from openFDA. This site is unofficial and independent of the FDA.