Company ยท US
Aspen Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1998. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 24 |
| EQH | Source, Carrier, Fiberoptic Light | 10 |
| KCY | Tourniquet, Pneumatic | 5 |
| DRX | Electrode, Electrocardiograph | 2 |
| FCT | Headlight, Fiberoptic Focusing | 2 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 2 |
| DZI | Drill, Bone, Powered | 1 |
| FQM | Bandage, Elastic | 1 |
| FSE | Table, Operating-Room, Manual | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 |
| FZX | Guide, Surgical, Instrument | 1 |
| GEX | Powered Laser Surgical Instrument | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 |
| HRX | Arthroscope | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 1998 | K981220 | SYSTEM 7500 ABC ELECTROSURGICAL UNIT Aspen Laboratories, Inc. | GEI |
| Sep 13, 1996 | K963088 | SHEATH, ELECTROSURGICAL PENCIL Aspen Laboratories, Inc. | GEI |
| Jul 11, 1996 | K955834 | SYSTEM 6500 ABC ELECTROSURGICAL UNIT Aspen Laboratories, Inc. | GEI |
| Feb 20, 1996 | K960296 | 4000 ETM Aspen Laboratories, Inc. | GEI |
| Oct 30, 1995 | K953081 | BEAMER PLUS Aspen Laboratories, Inc. | GEI |
| Aug 21, 1995 | K953007 | EXCALIBUR PLUS ELECTROSURGICAL UNIT Aspen Laboratories, Inc. | GEI |
| Apr 3, 1995 | K946104 | SMOKIEVAC ELECTROSURGICAL PENCIL Aspen Laboratories, Inc. | GEI |
| Dec 21, 1994 | K944012 | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR Aspen Laboratories, Inc. | GEI |
| Apr 16, 1993 | K924960 | EXCALIBUR ELECTROSURGICAL UNIT Aspen Laboratories, Inc. | GEI |
| Feb 13, 1992 | K913213 | SINGLE USE LEE ELECTRODE Aspen Laboratories, Inc. | HGI |
| Feb 13, 1990 | K896838 | BISTAT ELECTROSURGICAL UNIT 60-5400-001 Aspen Laboratories, Inc. | GEX |
| Feb 2, 1990 | K896839 | MF-450 ELECTROSURGICAL UNIT 60-5500-001 Aspen Laboratories, Inc. | GEI |
| Jul 31, 1987 | K872868 | ASPEN ESMARK BANDAGE Aspen Laboratories, Inc. | FQM |
| Jul 21, 1987 | K872661 | RGB CAMERA SYSTEM Aspen Laboratories, Inc. | FWF |
| Jun 8, 1987 | K871648 | TMJ CANNULA SET Aspen Laboratories, Inc. | DZI |
| Mar 18, 1987 | K870784 | A.T.S. 1500 TOURNIQUET Aspen Laboratories, Inc. | KCY |
| Oct 23, 1986 | K863590 | UNIVERSAL CANNULA SYSTEM Aspen Laboratories, Inc. | HRX |
| Aug 18, 1986 | K862564 | A.C.L. GUIDE KIT Aspen Laboratories, Inc. | FZX |
| Feb 28, 1986 | K854751 | ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE Aspen Laboratories, Inc. | EQH |
| Feb 25, 1986 | K860463 | SINGLE AND DUAL TOURNIQUET CUFF Aspen Laboratories, Inc. | KCY |
| Dec 2, 1985 | K854281 | MAGNETIC RETRIEVER Aspen Laboratories, Inc. | |
| Oct 8, 1985 | K853801 | MENISCAL STITCHING KIT Aspen Laboratories, Inc. | |
| Oct 7, 1985 | K853802 | ATS 500 TOURNIQUET Aspen Laboratories, Inc. | KCY |
| Sep 3, 1985 | K852355 | SINGLE USE ARTHROSCOPY ELECTRODE Aspen Laboratories, Inc. | GEI |
| Oct 25, 1984 | K843801 | MASON EQUIPMENT ORGANIZER & ASPEN Aspen Laboratories, Inc. | FSE |
| Jul 16, 1984 | K841558 | BANANA CUFF Aspen Laboratories, Inc. | KCY |
| Jun 3, 1983 | K831290 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR Aspen Laboratories, Inc. | GEI |
| Jun 2, 1983 | K831291 | ELECTROSURGICAL UNIT-MF 380 #60-1700 Aspen Laboratories, Inc. | GEI |
| Feb 15, 1983 | K823923 | MF 360B ELECTROSURGICAL UNIT Aspen Laboratories, Inc. | GEI |
| Dec 14, 1981 | K813231 | TOURNIQUET Aspen Laboratories, Inc. | KCY |
| Feb 27, 1981 | K810300 | FIBER OPTIC ADAPTERS#60-0893 Aspen Laboratories, Inc. | HBI |
| Feb 27, 1981 | K810299 | FIBER OPTIC ADAPTERS#60-0891 Aspen Laboratories, Inc. | HBI |
| Jan 29, 1981 | K810103 | ADULT ECG ELECTRODE #60-0724 Aspen Laboratories, Inc. | DRX |
| Jan 29, 1981 | K810102 | INFANT ECG ELECTRODE #60-1029 Aspen Laboratories, Inc. | DRX |
| Jan 29, 1981 | K810101 | WATER RESISTANT FOOTSWITCH W/CABLE Aspen Laboratories, Inc. | GEI |
| Dec 16, 1980 | K802775 | FIBER OPTIC ADAPTER #60-0896 Aspen Laboratories, Inc. | EQH |
| Dec 16, 1980 | K802774 | FIBER OPTIC ADAPTER #60-0892 Aspen Laboratories, Inc. | EQH |
| Dec 16, 1980 | K802773 | FIBER OPTIC LIGHT GUIDE #60-0767 Aspen Laboratories, Inc. | EQH |
| Dec 16, 1980 | K802772 | FIBER OPTIC ADAPTER #60-0894 Aspen Laboratories, Inc. | EQH |
| Dec 16, 1980 | K802771 | FIBER OPTIC ADAPTER #60-895 Aspen Laboratories, Inc. | EQH |
| Dec 16, 1980 | K802768 | FIBER OPTIC ADAPTER #60-0897 Aspen Laboratories, Inc. | EQH |
| Dec 16, 1980 | K802767 | FIBER OPTIC LIGHT GUIDE CAT#60-0768 Aspen Laboratories, Inc. | EQH |
| Dec 16, 1980 | K802766 | FIBER OPTIC ADAPTER CAT#60-0898 Aspen Laboratories, Inc. | EQH |
| Dec 11, 1980 | K802770 | FIBER OPTIC HEADLIGHT #60-0766766 Aspen Laboratories, Inc. | FCT |
| Dec 11, 1980 | K802769 | FIBER OPTIC HEADLIGHT #60-0765 Aspen Laboratories, Inc. | FCT |
| May 28, 1980 | K801176 | FIBER OPTIC LIGHT SOURCE Aspen Laboratories, Inc. | EQH |
| Apr 2, 1980 | K800597 | REUSABLE HAND-TROL Aspen Laboratories, Inc. | GEI |
| May 18, 1979 | K790770 | SAFETY HOLSTER, SINGLE-USE Aspen Laboratories, Inc. | GEI |
| Aug 31, 1978 | K781429 | HAND-TROL CONNECTOR EXTENDER Aspen Laboratories, Inc. | GEI |
| Jun 22, 1978 | K780978 | SINGLE USE ACTIVE ELECTRODE HANDLE Aspen Laboratories, Inc. | GEI |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||