SPECTRUM SILICONE FOLEY CATHETER— 510(k) K000251

Name: FDA 510(k) clearance K000251
Creator: U.S. Food and Drug Administration
Published: 2000-08-30

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K000251 for SPECTRUM SILICONE FOLEY CATHETER, Substantially Equivalent on 2000-08-30. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code MJC
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2000-01-27
Decision date: 2000-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MJC

view all

More clearances from Cook Urological, Inc.

view all

K102141 — COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)2011-05-06
K091767 — 3 WAY SILICONE FOLEY BALLOON CATHETER2009-10-09
K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-1224002009-09-03
K082066 — TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER2008-11-07
K082536 — COOK WIRE GUIDES2008-10-27

Adverse events under product code MJC

product code MJC

Injury: 398
Malfunction: 12,582
Other: 2
Total: 12,982

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.