510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K180469Substantially Equivalent

ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180469 is the FDA 510(k) clearance record for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent, a class II device, cleared for Coloplast Corp. on under FDA product code FAD (Stent, Ureteral). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K180469.

Clearance record

Decision date
Received
(258 days to decision)
Product code
FAD Stent, Ureteral
Regulation
21 CFR 876.4620
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Coloplast Corp. 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
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