510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061918Substantially Equivalent

Foley Catheters with Temperature Probe

GE Healthcare, Needham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061918 is the FDA 510(k) clearance record for FOLEY CATHETERS WITH TEMPERATURE PROBE, a class II device, cleared for GE Healthcare on under FDA product code EYC (Catheter, Upper Urinary Tract). FDA records list 888 510(k) clearances for GE Healthcare, from to . As of , FDA records show no recalls naming K061918.

Clearance record

Decision date
Received
(43 days to decision)
Product code
EYC Catheter, Upper Urinary Tract
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
GE Healthcare 86 Pilgrim Rd., Needham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EYC

Trailing 12 months

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

FDA records show no clearances under product code EYC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EYC, 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