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FDA 510(k)

ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX

K-Number: K083684 · 2009-02-05

ApplicantManufacturing & Research, Inc.
Decision Date2009-02-05
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX is the device name listed in this FDA 510(k) record. The listed applicant is Manufacturing & Research, Inc.. It received FDA 510(k) clearance on 2009-02-05 under 510(k) number K083684. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX?

ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX is a medical device that received FDA 510(k) clearance on 2009-02-05. The listed applicant is Manufacturing & Research, Inc.. The 510(k) number is K083684.

When did ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX receive FDA 510(k) clearance?

ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX received FDA 510(k) clearance on 2009-02-05, under 510(k) number K083684.

Who is the listed applicant for ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX?

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

What is the FDA product code for ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX?

The FDA product code for ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX is KNT.

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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.

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