DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER— 510(k) K024010

Clearance details

Applicant

The Kendall Company Div. of Tyco Healthcare Group

Product code

Code EZL

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

2002-12-04

Decision date

2003-06-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mansfield, MA, US

• K260756 — TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)2026-09-04
• K262056 — Rusch Latex Gold Foley Catheter2026-08-05
• K252537 — Rusch SoftSimplastic Foley Catheters2026-01-20
• K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter)2025-06-16
• K241424 — InnoCare Specialty Foley Catheter2024-09-18

• K831081 — EZEE FILTER/SEPARATOR1983-05-16
• K831082 — CONNECTING TUBING1983-05-09
• K831079 — LIQUIPETTE1983-04-28

Death

6

Injury

796

Malfunction

4,989

Other

1

Total

5,792

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1050-2024 — Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400 ML U/M FOLEY TRAY, LL, 16 FR (5.3 MM), 5 CC, 2-WAY; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY INSERTION TRAY, 5 CC, PREP TRAY, 16 FR (5.3 MM); Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 16 FR (5.3 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" 100% SILICONE SILVER-HYDROGEL COATED FOLEY TRAY, 18 FR (6.0 MM), 5CC, 2-WAY, 2000ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML DRAINAGE BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER-LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED COUD¿ TIP LATEX 400 ML U/M FOLEY TRAY, 16 FR (5.3 MM), 5 CC, 2000 ML BAGClass I·Ongoing·Cardinal Health 200, LLC·20231204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024010.