COMFORT CATH MALE EXTERNAL CATHETER— 510(k) K883057

Name: FDA 510(k) clearance K883057
Creator: U.S. Food and Drug Administration
Published: 1988-08-02

Substantially Equivalent

Sierra Laboratories, Inc.

FDA 510(k) clearance K883057 for COMFORT CATH MALE EXTERNAL CATHETER, Substantially Equivalent on 1988-08-02. Applicant: Sierra Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Sierra Laboratories, Inc.
Product code: Code EYT
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1988-07-19
Decision date: 1988-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EYT

view all

K934080 — URINARY DRAINAGE BAG1994-05-18
K935774 — CURITY FAST-CATH FEMALE CATHETER KIT1994-04-11
K883119 — VPI NON-ADHESIVE CONDOM CATHETER1988-08-02

More clearances from Sierra Laboratories, Inc.

view all

K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER1997-04-22
K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER1996-07-15
K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER1996-07-15
K934266 — COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER1994-04-19
K934052 — ALPINE REUSABLE LEG BAGS1994-01-07

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