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FDA 510(k)

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20

K-Number: K043027 · 2004-12-02

ApplicantApplied Medical Technology, Inc.
Decision Date2004-12-02
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Technology, Inc.. It received FDA 510(k) clearance on 2004-12-02 under 510(k) number K043027. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20?

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 is a medical device that received FDA 510(k) clearance on 2004-12-02. The listed applicant is Applied Medical Technology, Inc.. The 510(k) number is K043027.

When did MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 receive FDA 510(k) clearance?

MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 received FDA 510(k) clearance on 2004-12-02, under 510(k) number K043027.

Who is the listed applicant for MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20?

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

What is the FDA product code for MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20?

The FDA product code for MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 is KNT.

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Related Devices (Code: KNT)

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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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