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FDA 510(k)

NAJA Gastrointestinal Catheter

K-Number: K223890 · 2023-06-16

ApplicantChess Medical, Inc.
Decision Date2023-06-16
Product CodeFGD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NAJA Gastrointestinal Catheter is a medical device manufactured by Chess Medical, Inc.. It received FDA 510(k) clearance on 2023-06-16 under approval number K223890. The device is classified under product code FGD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAJA Gastrointestinal Catheter?

NAJA Gastrointestinal Catheter is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Chess Medical, Inc.. The 510(k) number is K223890.

When was NAJA Gastrointestinal Catheter approved by the FDA?

NAJA Gastrointestinal Catheter received FDA 510(k) clearance on 2023-06-16, under approval number K223890.

What company makes NAJA Gastrointestinal Catheter?

NAJA Gastrointestinal Catheter is manufactured by Chess Medical, Inc..

What is the FDA product code for NAJA Gastrointestinal Catheter?

The FDA product code for NAJA Gastrointestinal Catheter is FGD.

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Official Source

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