Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 2017-02-15 under 510(k) 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. The listed applicant is Medela, Inc.. The 510(k) number is K161811.

When did Medela Low Dose Enteral Syringe receive FDA 510(k) clearance?

Medela Low Dose Enteral Syringe received FDA 510(k) clearance on 2017-02-15, under 510(k) number K161811.

Who is the listed applicant for Medela Low Dose Enteral Syringe?

The FDA 510(k) record lists Medela, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Medela, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 19 devices →

Related Devices (Code: PNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.