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)

ENFit Disposable Enteral Syringe

K-Number: K203410 · 2021-06-28

Decision Date2021-06-28
Product CodePNR
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENFit Disposable Enteral Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2021-06-28 under 510(k) number K203410. 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 ENFit Disposable Enteral Syringe?

ENFit Disposable Enteral Syringe is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K203410.

When did ENFit Disposable Enteral Syringe receive FDA 510(k) clearance?

ENFit Disposable Enteral Syringe received FDA 510(k) clearance on 2021-06-28, under 510(k) number K203410.

Who is the listed applicant for ENFit Disposable Enteral Syringe?

The FDA 510(k) record lists Shantou Wealy Medical Instrument Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENFit Disposable Enteral Syringe?

The FDA product code for ENFit Disposable Enteral Syringe is PNR.

Other records listing Shantou Wealy Medical Instrument Co.,Ltd 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.

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.