510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991219Substantially Equivalent

C-Flex Ureteral Stents

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

K991219 is the FDA 510(k) clearance record for C-FLEX URETERAL STENTS, a class II device, cleared for Applied Medical Resources on under FDA product code FAD (Stent, Ureteral). FDA records list 115 510(k) clearances for Applied Medical Resources, from to . As of , FDA records show 6 recalls naming K991219.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FAD Stent, Ureteral
Regulation
21 CFR 876.4620
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 FAD

Trailing 12 months
2 clearances under product code FAD in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FAD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260