510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K973891Substantially Equivalent

Laparoscopic Gastrostomy Kit

Applied Medical Resources Corp, Launa Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973891 is the FDA 510(k) clearance record for LAPAROSCOPIC GASTROSTOMY KIT, a class II device, cleared for Applied Medical Resources on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 115 510(k) clearances for Applied Medical Resources, from to . As of , FDA records show no recalls naming K973891.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Applied Medical Resources 26051 Merit Cir., Launa Hills CA
510(k) summary
Summary
Third party review
No

Clearances, product code KNT

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