NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps— 510(k) K152857
Substantially EquivalentNeomed, Inc.
FDA 510(k) clearance K152857 for NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps, Substantially Equivalent on 2015-12-17. 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)
- K161039 — 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)
- 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.