CONE CATH— 510(k) K931156

Substantially Equivalent

Sierra Laboratories, Inc.

FDA 510(k) clearance K931156 for CONE CATH, Substantially Equivalent on 1993-07-01. Applicant: Sierra Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Sierra Laboratories, Inc.
Product code: Code EXJ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1993-03-09
Decision date: 1993-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXJ

K970465 — BOUSER'S URINAL1997-12-18
K972100 — VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)1997-07-31
K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER1997-04-22
K963265 — PROSYS SAMEC LA1996-10-25
K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER1996-09-16

More clearances from Sierra Laboratories, Inc.

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
K901000 — URO TEX URINALS1990-03-26

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