510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083685Substantially Equivalent

Endovive Low Profile Replacement Gastrostomy Tube, Model 82Xx, 8283, 8284, 8285

Mri Manufacturing and Research, Inc., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083685 is the FDA 510(k) clearance record for ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285, a class II device, cleared for Mri Manufacturing and Research, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 3 510(k) clearances for Mri Manufacturing and Research, Inc., from to . As of , FDA records show no recalls naming K083685.

Clearance record

Decision date
Received
(195 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mri Manufacturing and Research, Inc. 4700 S. Overland Dr., Tucson AZ
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code KNT

Trailing 12 months
3 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20261
October 20260