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FDA 510(k)

BONREE Nelaton Catheter

K-Number: K212430 · 2022-04-29

ApplicantBonree Medical Co., Ltd.
Decision Date2022-04-29
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BONREE Nelaton Catheter is a medical device manufactured by Bonree Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-04-29 under approval number K212430. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONREE Nelaton Catheter?

BONREE Nelaton Catheter is a medical device that received FDA 510(k) clearance on 2022-04-29. It is manufactured by Bonree Medical Co., Ltd.. The 510(k) number is K212430.

When was BONREE Nelaton Catheter approved by the FDA?

BONREE Nelaton Catheter received FDA 510(k) clearance on 2022-04-29, under approval number K212430.

What company makes BONREE Nelaton Catheter?

BONREE Nelaton Catheter is manufactured by Bonree Medical Co., Ltd..

What is the FDA product code for BONREE Nelaton Catheter?

The FDA product code for BONREE Nelaton Catheter is EZD.

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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.

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