510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260999Substantially Equivalent

LoFric Elle Pro

Wellspect Inc., Mölndal, SE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260999 is the FDA 510(k) clearance record for LoFric Elle Pro, a class II device, cleared for Wellspect AB on under FDA product code EZD (Catheter, Straight). FDA records list 3 510(k) clearances for Wellspect AB, from to . As of , FDA records show no recalls naming K260999.

Clearance record

Decision date
Received
(29 days to decision)
Product code
EZD Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Wellspect AB Amniogatan 1, P.O.Box 14, Mölndal, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EZD

Trailing 12 months
11 clearances under product code EZD in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20261
April 20262
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260