FDA 510(k)

Enteral Pump Syringe

K-Number: K211593 · 2021-09-30

Decision Date2021-09-30

Product CodePNR

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Enteral Pump Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2021-09-30 under 510(k) number K211593. 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 Enteral Pump Syringe?

Enteral Pump Syringe is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K211593.

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

Enteral Pump Syringe received FDA 510(k) clearance on 2021-09-30, under 510(k) number K211593.

Who is the listed applicant for Enteral Pump Syringe?

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

What is the FDA product code for Enteral Pump Syringe?

The FDA product code for Enteral Pump Syringe is PNR.

Other records listing Jiangsu Caina Medical 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.