FDA 510(k)

ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285

K-Number: K083685 · 2009-06-25

ApplicantMri Manufacturing and Research, Inc.

Decision Date2009-06-25

Product CodeKNT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 is the device name listed in this FDA 510(k) record. The listed applicant is Mri Manufacturing and Research, Inc.. It received FDA 510(k) clearance on 2009-06-25 under 510(k) number K083685. 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 ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285?

ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 is a medical device that received FDA 510(k) clearance on 2009-06-25. The listed applicant is Mri Manufacturing and Research, Inc.. The 510(k) number is K083685.

When did ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 receive FDA 510(k) clearance?

ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 received FDA 510(k) clearance on 2009-06-25, under 510(k) number K083685.

Who is the listed applicant for ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285?

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

What is the FDA product code for ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285?

The FDA product code for ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 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.