510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971498Substantially Equivalent

Applied Medical Laparoscopic Guidewire

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

K971498 is the FDA 510(k) clearance record for APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE, a class I device, cleared for Applied Medical Resources on under FDA product code EZB (Stylet For Catheter, Gastro-Urology). FDA records list 115 510(k) clearances for Applied Medical Resources, from to . As of , FDA records show no recalls naming K971498.

Clearance record

Decision date
Received
(10 days to decision)
Product code
EZB Stylet For Catheter, Gastro-Urology
Regulation
21 CFR 876.5130
Device class
Class I
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 EZB

Trailing 12 months

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

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