Medical Device Manufacturer · US , Mchenry , IL

Sage Products, Inc.

31 submissions · 30 cleared · Since 1978
31
Total
30
Cleared
0
Denied

Sage Products, Inc. — FDA 510(k) Submissions

Sage Products, Inc. has submitted 31 FDA 510(k) premarket notifications since 1978, of which 30 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Container, Sharps, Container, Specimen, Sterile, Needle, Hypodermic, Single Lumen, Device, Specimen Collection, Container, Specimen Mailer And Storage, Sterile . Use the specialty filter in the sidebar to narrow results.

31 devices
1–25 of 31
RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
K972705 · FMI Needle, Hypodermic,... · General Hospital
Apr 1998 283d
SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS
K980490 · MMK Container, Sharps · General Hospital
Feb 1998 15d
2 GALLON ALTERNATE CARE SHARPS CONTAINER
K973911 · FMI Needle, Hypodermic,... · General Hospital
Oct 1997 15d
SHARPS SHUTTLE
K972279 · FMI Needle, Hypodermic,... · General Hospital
Aug 1997 72d
NITRILE GLOVES
K970135 · LZC Medical Glove, Specialty · General Hospital
Aug 1997 222d
POCKET COUNT OR SAFETCOUNT
K972302 · LWH Counter, Sponge, Surgical · General & Plastic Surgery
Jul 1997 36d
PROCEDURE SPECIFIC KITS
K964168 · FXX Mask, Surgical · General Hospital
Mar 1997 137d
STP SYSTEM PVA WITH ZINC
K963986 · LIO Device, Specimen Collection · Microbiology
Nov 1996 35d
STP SYSTEM - SAF
K964026 · LIO Device, Specimen Collection · Microbiology
Nov 1996 31d
STP SYSTEM-PVA WITH MERCURY
K964027 · LIO Device, Specimen Collection · Microbiology
Nov 1996 25d
MUCUS SPECIMEN TRAP
K962168 · KDQ Bottle, Collection, Vacuum · General Hospital
Jul 1996 47d
CHEMOTHERAPY WASTE DISPOSAL CONTAINERS
K943658 · MMK Container, Sharps · General Hospital
Mar 1995 238d
ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS
K943659 · MMK Container, Sharps · General Hospital
Mar 1995 238d
PHLEBOTOMY SHARPS DISPOSAL CONTAINERS
K943660 · MMK Container, Sharps · General Hospital
Mar 1995 238d
IN-ROOM AND SHARPSTAR
K941991 · MMK Container, Sharps · General Hospital
Aug 1994 126d
STOOL TRANSPORT/PROCESSOR
K933370 · LKS Device, Parasite... · Microbiology
Feb 1994 223d
SUCTION ORA-SWAB(R) BRUSH KIT
K901806 · EIA Unit, Operative Dental · Dental
Aug 1990 117d
STERILE HAND COVER
K894064 · LYU Accessory, Surgical Apparel · General Hospital
Aug 1989 64d
ISOLATION GOWN
K874888 · FYC Gown, Isolation, Surgical · General Hospital
Dec 1987 29d
BLOOD NEEDLE HOLDER
K873569 · FMI Needle, Hypodermic,... · General Hospital
Nov 1987 62d
MOUTH CARE KIT W/TOOTHBRUSH
K823413 · Dental
Mar 1983 134d
PEDIATRIC URINE COLLECTOR
K823411 · KNX Collector, Urine, (and... · Gastroenterology & Urology
Dec 1982 43d
ARM BOARD W/I.V COVERING
K823412 · BTX Board, Arm (with Cover),... · General & Plastic Surgery
Dec 1982 30d
PREFILLED SPECIMEN CONTAINER
K820246 · KDT Container, Specimen... · Pathology
Feb 1982 20d
SAGE 2200 STERILE SPECIMEN CONTAINER
K813408 · FMT Warmer, Infant Radiant · Radiology
Jan 1982 49d
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