Medela Low Dose Enteral Syringe
K-Number: K161811 · 2017-02-15
ApplicantMedela, Inc.
Decision Date2017-02-15
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Medela Low Dose Enteral Syringe is a medical device manufactured by Medela, Inc.. It received FDA 510(k) clearance on 2017-02-15 under approval number K161811. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Medela Low Dose Enteral Syringe?
Medela Low Dose Enteral Syringe is a medical device that received FDA 510(k) clearance on 2017-02-15. It is manufactured by Medela, Inc.. The 510(k) number is K161811.
When was Medela Low Dose Enteral Syringe approved by the FDA?
Medela Low Dose Enteral Syringe received FDA 510(k) clearance on 2017-02-15, under approval number K161811.
What company makes Medela Low Dose Enteral Syringe?
Medela Low Dose Enteral Syringe is manufactured by Medela, Inc..
What is the FDA product code for Medela Low Dose Enteral Syringe?
The FDA product code for Medela Low Dose Enteral Syringe is PNR.
Other Devices by Medela, Inc.
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K161039NeoConnect 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)Neomed, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.