Monoject
FDA 510(k) K161045 · Covidien
510(k) numberK161045
Submission
- Device name
- Monoject
- Applicant
- Covidien
Mansfield, MA, US - Received
- April 13, 2016
- Decision date
- June 17, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNR – Enteral Syringes With Enteral Specific Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Delivers nutrition, medication, or hydration orally or to a gastrointestinal tube or extension set using AAMI/CN3(PS):2014 compliant connectors.
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| K211025 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | Ningbo Tianyi Medical Appliance Co., Ltd. | 06/30/2021SE |
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Questions and answers
When was Monoject cleared by the FDA?
Monoject (K161045) received a 510(k) decision of Substantially Equivalent on June 17, 2016, 65 days after the submission was received.
What is the product code of K161045?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.