Medical Device Manufacturer · US , Mchenry , IL

Sierra Laboratories, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1979
12
Total
12
Cleared
0
Denied

Sierra Laboratories, Inc. has 12 FDA 510(k) cleared gastroenterology & urology devices. Based in Mchenry, US.

Historical record: 12 cleared submissions from 1979 to 1997.

Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.

12 devices
1–12 of 12
COMFORT CATH CHOICE MALE EXTERNAL CATHETER
K970966 · EXJ Device, Incontinence, Urosheath Type, Sterile · Gastroenterology & Urology
Apr 1997 36d
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
K962384 · EXJ Device, Incontinence, Urosheath Type, Sterile · Gastroenterology & Urology
Jul 1996 25d
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
K962413 · EXJ Device, Incontinence, Urosheath Type, Sterile · Gastroenterology & Urology
Jul 1996 24d
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER
K934266 · EXJ Device, Incontinence, Urosheath Type, Sterile · Gastroenterology & Urology
Apr 1994 231d
ALPINE REUSABLE LEG BAGS
K934052 · FAQ Bag, Urine Collection, Leg, For External Use, Sterile · Gastroenterology & Urology
Jan 1994 141d
CONE CATH
K931156 · EXJ Device, Incontinence, Urosheath Type, Sterile · Gastroenterology & Urology
Jul 1993 114d
URO TEX URINALS
K901000 · EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile · Gastroenterology & Urology
Mar 1990 24d
COMFORT CATH MALE EXTERNAL CATHETER
K883057 · EYT Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile · Gastroenterology & Urology
Aug 1988 14d
MODEL 820 TOP=TRAK
K873039 · BYN Chair, Posture, For Cardiac And Pulmonary Treatment · Anesthesiology
Feb 1988 191d
URO-TEX MALE EXTERNAL CATHETER
K832450 · KNX Collector, Urine, (and Accessories) For Indwelling Catheter · Gastroenterology & Urology
Oct 1983 80d
SKIN STAPLE EXTRACTOR
K811887 · KBC Saw, Nasal · Ear, Nose, Throat
Jul 1981 26d
AMALGAMATOR MODEL SDC--
K791410 · EFD Amalgamator, Dental, Ac-powered · Dental
Sep 1979 69d
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