ZIP CONDOM CATHETER— 510(k) K964219

Substantially Equivalent

Goulter Medical, Inc.

FDA 510(k) clearance K964219 for ZIP CONDOM CATHETER, Substantially Equivalent on 1997-08-11. Applicant: Goulter Medical, Inc.. Device class: 1.

Clearance details

Applicant: Goulter Medical, Inc.
Product code: Code EYZ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1996-10-22
Decision date: 1997-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EYZ

K961906 — UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,100181996-11-19
K952780 — URINARY GEL DRAINAGE SYSTEM1995-12-12
K951597 — URINARY DRAINAGE BAG1995-08-04
K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER1994-11-02
K933126 — COMFORTCARE SYSTEM1994-02-25

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