NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)— 510(k) K161039
Substantially EquivalentNeomed, Inc.
FDA 510(k) clearance K161039 for NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL), Substantially Equivalent on 2016-06-17. Applicant: Neomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Neomed, Inc.
- Product code
- Code PNR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Woodstock, GA, US
Recent devices under product code PNR
view allMore clearances from Neomed, Inc.
view all- K183540 — Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
- K152857 — NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
- K143344 — NeoMed NeoConnect Enteral Syringes with ENFit Connector
- K122373 — NEOMED ORAL/ENTERAL SYRINGE
- K120182 — NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
Adverse events under product code PNR
product code PNR- Other
- 6
- Total
- 6
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.