510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981591Substantially Equivalent

Vortek Ureteral Double Loop Stent, Biosoft Ureteral Double Loop Stent

International Regulatory Consultants, Salt Lake City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K981591 is the FDA 510(k) clearance record for VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT, a class II device, cleared for International Regulatory Consultants on under FDA product code FAD (Stent, Ureteral). FDA records list 5 510(k) clearances for International Regulatory Consultants, from to . As of , FDA records show no recalls naming K981591.

Clearance record

Decision date
Received
(158 days to decision)
Product code
FAD Stent, Ureteral
Regulation
21 CFR 876.4620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
International Regulatory Consultants 2471 E. Shadow Wood Cir., Salt Lake City UT
510(k) summary
Statement
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