510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K925918Substantially Equivalent

Pressure Turing and Accessories

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

K925918 is the FDA 510(k) clearance record for PRESSURE TURING AND ACCESSORIES, a class II device, cleared for Applied Medical Resources on under FDA product code GCM (Endoscope, Rigid). FDA records list 115 510(k) clearances for Applied Medical Resources, from to . As of , FDA records show no recalls naming K925918.

Clearance record

Decision date
Received
(81 days to decision)
Product code
GCM Endoscope, Rigid
Regulation
21 CFR 876.1500
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 GCM

Trailing 12 months

FDA records hold no clearances under product code GCM in the trailing twelve months.

FDA records show no clearances under product code GCM in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GCM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260