Medela Low Dose Enteral Syringe
FDA 510(k) K161811 · Medela, Inc.
510(k) numberK161811
Submission
- Device name
- Medela Low Dose Enteral Syringe
- Applicant
- Medela, Inc.
Brea, CA, US - Received
- July 1, 2016
- Decision date
- February 15, 2017
- 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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| K231300 | Nutricair Enteral Syringe with ENFitPNR · Traditional | Cair Lgl | 10/06/2023SE |
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| K211661 | ENFit enteral syringes (NUTRIFIT)PNR · Traditional | Pentaferte Italia S.R.L. | 02/28/2022SE |
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| K203613 | ENFit Reusable Enteral SyringePNR · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 08/27/2021SE |
| 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 Medela Low Dose Enteral Syringe cleared by the FDA?
Medela Low Dose Enteral Syringe (K161811) received a 510(k) decision of Substantially Equivalent on February 15, 2017, 229 days after the submission was received.
What is the product code of K161811?
The FDA product code is PNR – Enteral Syringes With Enteral Specific Connectors, a Class II (moderate risk) device regulated under 21 CFR 876.5980.