Medical Device Manufacturer · US , Mchenry , IL

Aspen Laboratories, Inc.

55 submissions · 55 cleared · Since 1976
55
Total
55
Cleared
0
Denied

Aspen Laboratories, Inc. — FDA 510(k) Submissions

Aspen Laboratories, Inc. has submitted 55 FDA 510(k) premarket notifications since 1976, of which 55 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Source, Carrier, Fiberoptic Light, Tourniquet, Pneumatic, Headlight, Fiberoptic Focusing, Electrode, Electrocardiograph . Use the specialty filter in the sidebar to narrow results.

55 devices
1–25 of 55
SYSTEM 7500 ABC ELECTROSURGICAL UNIT
K981220 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 1998 18d
SHEATH, ELECTROSURGICAL PENCIL
K963088 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 1996 36d
SYSTEM 6500 ABC ELECTROSURGICAL UNIT
K955834 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 1996 198d
4000 ETM
K960296 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 1996 29d
BEAMER PLUS
K953081 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 1995 119d
EXCALIBUR PLUS ELECTROSURGICAL UNIT
K953007 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Aug 1995 54d
SMOKIEVAC ELECTROSURGICAL PENCIL
K946104 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 1995 110d
ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR
K944012 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 1994 127d
EXCALIBUR ELECTROSURGICAL UNIT
K924960 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 1993 198d
SINGLE USE LEE ELECTRODE
K913213 · HGI Electrocautery,... · Obstetrics & Gynecology
Feb 1992 209d
BISTAT ELECTROSURGICAL UNIT 60-5400-001
K896838 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 1990 70d
MF-450 ELECTROSURGICAL UNIT 60-5500-001
K896839 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 1990 59d
ASPEN ESMARK BANDAGE
K872868 · FQM Bandage, Elastic · General Hospital
Jul 1987 10d
RGB CAMERA SYSTEM
K872661 · FWF Camera, Television,... · General & Plastic Surgery
Jul 1987 14d
TMJ CANNULA SET
K871648 · DZI Drill, Bone, Powered · Dental
Jun 1987 41d
A.T.S. 1500 TOURNIQUET
K870784 · KCY Tourniquet, Pneumatic · General & Plastic Surgery
Mar 1987 20d
UNIVERSAL CANNULA SYSTEM
K863590 · HRX Arthroscope · Orthopedic
Oct 1986 38d
A.C.L. GUIDE KIT
K862564 · FZX Guide, Surgical, Instrument · General & Plastic Surgery
Aug 1986 46d
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE
K854751 · EQH Source, Carrier,... · Ear, Nose, Throat
Feb 1986 94d
SINGLE AND DUAL TOURNIQUET CUFF
K860463 · KCY Tourniquet, Pneumatic · General & Plastic Surgery
Feb 1986 19d
MAGNETIC RETRIEVER
K854281 · General & Plastic Surgery
Dec 1985 39d
MENISCAL STITCHING KIT
K853801 · General & Plastic Surgery
Oct 1985 27d
ATS 500 TOURNIQUET
K853802 · KCY Tourniquet, Pneumatic · General & Plastic Surgery
Oct 1985 26d
SINGLE USE ARTHROSCOPY ELECTRODE
K852355 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 1985 92d
MASON EQUIPMENT ORGANIZER & ASPEN
K843801 · FSE Table, Operating-room,... · General & Plastic Surgery
Oct 1984 28d
Filters