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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 the device name listed in this FDA 510(k) record. The listed applicant is Chess Medical, Inc.. It received FDA 510(k) clearance on 2023-06-16 under 510(k) 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. The listed applicant is Chess Medical, Inc.. The 510(k) number is K223890.

When did NAJA Gastrointestinal Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for NAJA Gastrointestinal Catheter?

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

What is the FDA product code for NAJA Gastrointestinal Catheter?

The FDA product code for NAJA Gastrointestinal Catheter is FGD.

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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