Aspen Laboratories, Inc.
Medical device manufacturer in Centennial, CO.
55510(k) clearances
0PMA approvals
0recalls
Device types
- GEI Electrosurgical, Cutting & Coagulation &… 24
- EQH Source, Carrier, Fiberoptic Light 10
- KCY Tourniquet, Pneumatic 5
- FCT Headlight, Fiberoptic Focusing 2
- DRX Electrode, Electrocardiograph 2
- HBI Illuminator, Fiberoptic, Surgical Field 2
- FSE Table, Operating-Room, Manual 1
- FZX Guide, Surgical, Instrument 1
- HRX Arthroscope 1
- DZI Drill, Bone, Powered 1
- FWF Camera, Television, Endoscopic, Without Audio 1
- FQM Bandage, Elastic 1
- GEX Powered Laser Surgical Instrument 1
- HGI Electrocautery, Gynecologic (And Accessories) 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K981220 | System 7500 Abc Electrosurgical UnitGEI · Traditional | 04/21/1998SE |
| K963088 | Sheath, Electrosurgical PencilGEI · Traditional | 09/13/1996SE |
| K955834 | System 6500 Abc Electrosurgical UnitGEI · Traditional | 07/11/1996SE |
| K960296 | 4000 EtmGEI · Traditional | 02/20/1996SE |
| K953081 | Beamer PlusGEI · Traditional | 10/30/1995SE |
| K953007 | Excalibur Plus Electrosurgical UnitGEI · Traditional | 08/21/1995SE |
| K946104 | Smokievac Electrosurgical PencilGEI · Traditional | 04/03/1995SE |
| K944012 | Electrosurgical Flexible Electrode In-Line Suction CoagulatorGEI · Traditional | 12/21/1994SE |
| K924960 | Excalibur Electrosurgical UnitGEI · Traditional | 04/16/1993SE |
| K913213 | Single Use Lee ElectrodeHGI · Traditional | 02/13/1992SE |
| K896838 | Bistat Electrosurgical Unit 60-5400-001GEX · Traditional | 02/13/1990SE |
| K896839 | MF-450 Electrosurgical Unit 60-5500-001GEI · Traditional | 02/02/1990SE |
| K872868 | Aspen Esmark BandageFQM · Traditional | 07/31/1987SE |
| K872661 | RGB Camera SystemFWF · Traditional | 07/21/1987SE |
| K871648 | TMJ Cannula SetDZI · Traditional | 06/08/1987SE |
| K870784 | A.T.S. 1500 TourniquetKCY · Traditional | 03/18/1987SE |
| K863590 | Universal Cannula SystemHRX · Traditional | 10/23/1986SE |
| K862564 | A.C.L. Guide KitFZX · Traditional | 08/18/1986SE |
| K854751 | Zimmer Video Products Automatic Light SourceEQH · Traditional | 02/28/1986SE |
| K860463 | Single and Dual Tourniquet CuffKCY · Traditional | 02/25/1986SE |
| K854281 | Magnetic Retriever · Traditional | 12/02/1985SE |
| K853801 | Meniscal Stitching Kit · Traditional | 10/08/1985SE |
| K853802 | Ats 500 TourniquetKCY · Traditional | 10/07/1985SE |
| K852355 | Single Use Arthroscopy ElectrodeGEI · Traditional | 09/03/1985SE |
| K843801 | Mason Equipment Organizer & AspenFSE · Traditional | 10/25/1984SE |
| K841558 | Banana CuffKCY · Traditional | 07/16/1984SE |
| K831290 | Electrode, Flexible Suction CoagulatorGEI · Traditional | 06/03/1983SE |
| K831291 | Electrosurgical Unit-Mf 380 #60-1700GEI · Traditional | 06/02/1983SE |
| K823923 | MF 360B Electrosurgical UnitGEI · Traditional | 02/15/1983SE |
| K813231 | TourniquetKCY · Traditional | 12/14/1981SE |
| K810300 | Fiber Optic ADAPTERS#60-0893HBI · Traditional | 02/27/1981SE |
| K810299 | Fiber Optic ADAPTERS#60-0891HBI · Traditional | 02/27/1981SE |
| K810103 | Adult ECG Electrode #60-0724DRX · Traditional | 01/29/1981SE |
| K810102 | Infant ECG Electrode #60-1029DRX · Traditional | 01/29/1981SE |
| K810101 | Water Resistant Footswitch W/CableGEI · Traditional | 01/29/1981SE |
| K802775 | Fiber Optic Adapter #60-0896EQH · Traditional | 12/16/1980SE |
| K802774 | Fiber Optic Adapter #60-0892EQH · Traditional | 12/16/1980SE |
| K802773 | Fiber Optic Light Guide #60-0767EQH · Traditional | 12/16/1980SE |
| K802772 | Fiber Optic Adapter #60-0894EQH · Traditional | 12/16/1980SE |
| K802771 | Fiber Optic Adapter #60-895EQH · Traditional | 12/16/1980SE |
| K802768 | Fiber Optic Adapter #60-0897EQH · Traditional | 12/16/1980SE |
| K802767 | Fiber Optic Light Guide CAT#60-0768EQH · Traditional | 12/16/1980SE |
| K802766 | Fiber Optic Adapter CAT#60-0898EQH · Traditional | 12/16/1980SE |
| K802770 | Fiber Optic Headlight #60-0766766FCT · Traditional | 12/11/1980SE |
| K802769 | Fiber Optic Headlight #60-0765FCT · Traditional | 12/11/1980SE |
| K801176 | Fiber Optic Light SourceEQH · Traditional | 05/28/1980SE |
| K800597 | Reusable Hand-TrolGEI · Traditional | 04/02/1980SE |
| K790770 | Safety Holster, Single-UseGEI · Traditional | 05/18/1979SE |
| K781429 | Hand-Trol Connector ExtenderGEI · Traditional | 08/31/1978SE |
| K780978 | Single Use Active Electrode HandleGEI · Traditional | 06/22/1978SE |
| K780977 | Single Use Blade ElectrodeGEI · Traditional | 06/22/1978SE |
| K780976 | Single Use Ball ElectrodeGEI · Traditional | 06/22/1978SE |
| K780975 | Single Use Needle ElectrodeGEI · Traditional | 06/22/1978SE |
| K771007 | Electrosurgical Power GeneratorsGEI · Traditional | 09/30/1977SE |
| K760675 | Electrosurgical Dispersive PlateGEI · Traditional | 12/28/1976SE |