Concept, Inc.
Medical device manufacturer in Largo, FL.
83510(k) clearances
1PMA approvals
0recalls
Device types
- HRX Arthroscope 10
- GEI Electrosurgical, Cutting & Coagulation &… 10
- HWC Screw, Fixation, Bone 4
- HNL Probe, Lachrymal 3
- HKP Instrument, Vitreous Aspiration And… 2
- KNT Tubes, Gastrointestinal (And Accessories) 2
- ETD Tube, Tympanostomy 2
- KGS Retention Device, Suture 2
- HJK Lens, Contact, Polymethylmethacrylate… 1
- BTR Tube, Tracheal (W/Wo Connector) 1
- JOS Electrode, Electrosurgical 1
- BTM Ventilator, Emergency, Manual (Resuscitator) 1
- KYT Light, Examination, Medical, Battery Powered 1
- DSK Computer, Blood-Pressure 1
- DRX Electrode, Electrocardiograph 1
- HSX Prosthesis, Knee, Femorotibial… 1
- GBQ Catheter, Continuous Irrigation 1
- HMX Cannula, Ophthalmic 1
- JOK Scissors, Medical, Disposable 1
- HNI Retractor, Ophthalmic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K912640 | Concept Endosteal Fixation DeviceHWC · Traditional | 05/01/1992SE |
| K912957 | Concept MicromillHRX · Traditional | 10/04/1991SE |
| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
| K894929 | Staple Fixation SystemJDR · Traditional | 08/30/1989SE |
| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
| K882121 | C-Flo Suction TubeDXQ · Traditional | 06/20/1988SE |
| K880414 | Tendon HarvesterHRX · Traditional | 03/25/1988SE |
| K874676 | Interference ScrewHWC · Traditional | 03/07/1988SE |
| K880413 | Patellar Tendon Graft GuideLXH · Traditional | 03/04/1988SE |
| K874515 | Concept Suture NeedleHRX · Traditional | 11/27/1987SE |
| K874439 | Soft Tissue Anchoring Set KitLRO · Traditional | 11/20/1987SE |
| K873030 | Concept Arthroscopic Portal RodHRX · Traditional | 09/16/1987SE |
| K872608 | Hewson A.C.L. Guide SetKGS · Traditional | 09/16/1987SE |
| K873009 | Concept Switching StickKGZ · Traditional | 08/17/1987SE |
| K872156 | Concept Self Compressing Cannulated Screw SystemHWC · Traditional | 07/21/1987SE |
| K871037 | Cancellous Fixation Screw & Washer for Use W/ScrewHWC · Traditional | 03/25/1987SE |
| K863396 | Concept Intravision Arthroscope SystemHRX · Traditional | 09/12/1986SE |
| K862659 | Concept Arthroscopy RaspHTP · Traditional | 09/02/1986SE |
| K862658 | Concept Arthroscopic KnifeHRX · Traditional | 07/23/1986SE |
| K862657 | Concept CuretteHRX · Traditional | 07/23/1986SE |
| K853829 | Meniscal Repair System · Traditional | 10/08/1985SE |
| K851040 | Concept Defrere ElectrodeGEI · Traditional | 07/11/1985SE |
| K851339 | Precision Harvest & Inlay Instrument SetHWK · Traditional | 07/02/1985SE |
| K850749 | Concept Video Imaging SystemKQM · Traditional | 05/20/1985SE |
| K850423 | Concept Suction SleeveHTZ · Traditional | 03/14/1985SE |
| K850714 | C.A.D. Pack I -Arthroscopy Drape Pack · Traditional | 03/06/1985SE |
| K850645 | Intra-Arc Disposable Arthroplasty Burrs · Traditional | 03/06/1985SE |
| K850462 | Concept Camera Drape · Traditional | 02/26/1985SE |
| K843925 | Gill's Irrigator/Aspirator NeedleGAA · Traditional | 11/05/1984SE |
| K842710 | Concept C-VacGCY · Traditional | 10/31/1984SE |
| K841483 | All Purpose Electrosurgical GeneratorGEI · Traditional | 10/23/1984SE |
| K843491 | Concept Fiber Optic Canaliculus IntubaHNL · Traditional | 10/05/1984SE |
| K843490 | Tube-StatBSR · Traditional | 10/04/1984SE |
| K840558 | Shutt Precision ProbesHXB · Traditional | 04/25/1984SE |
| K833856 | C-Loops · Traditional | 02/04/1984SE |
| K834069 | Arthroscan Video SystemFWF · Traditional | 01/27/1984SE |
| K833940 | Torque Plus Catalog 30120HWE · Traditional | 12/28/1983SE |
| K833441 | Dry GelGEI · Traditional | 11/29/1983SE |
| K833624 | Shutt Universal Stress PostFWZ · Traditional | 11/28/1983SE |
| K833076 | C-Flex Medical Grade TubingFPK · Traditional | 11/21/1983SE |
| K833061 | C-Flex Penrose Drainage TubeFFA · Traditional | 11/07/1983SE |
| K832362 | Donaldson-Type Vent TubeETD · Traditional | 10/14/1983SE |
| K832361 | Concept T-TubeETD · Traditional | 10/14/1983SE |
| K830800 | C-LoopsKDC · Traditional | 10/04/1983SE |
| K832278 | Light Handle CoverKKX · Traditional | 09/29/1983SE |
| K832293 | Enternal Feeding TubeKNT · Traditional | 09/12/1983SE |
| K830434 | Disposable Intra-Articular BladeGFA · Traditional | 04/12/1983SE |
| K830499 | Esa Electrosurgical Arthroscopy GeneraHRX · Traditional | 03/17/1983SE |
| K823424 | Meniscectomy Tray #9715HAW · Traditional | 03/17/1983SE |
| K823832 | Esa Arthroscopy Cannula TrayHRX · Traditional | 02/23/1983SE |
| K823516 | Esa CameraFWH · Traditional | 12/30/1982SE |
| K823184 | Bipolar Coagulator #9620/9621GEI · Traditional | 12/03/1982SE |
| K823174 | Microsurgical InstrumentsHNR · Traditional | 11/16/1982SE |
| K812722 | Safe GuardGEI · Traditional | 11/05/1981SE |
| K802845 | Concept Canaliculus Intubation SetHNL · Traditional | 12/17/1980SE |
| K802605 | Electro Surgical Tip CleanerGEI · Traditional | 11/12/1980SE |
| K801213 | Concept Endotracheal TubeBTR · Traditional | 05/28/1980SE |
| K800321 | Concept Suction CoagulatorKNS · Traditional | 02/28/1980SE |
| K792365 | Bipolar ForcepsJOS · Traditional | 12/10/1979SE |
| K792044 | Safe Return Cot. #9675 & Connector AdaptGEI · Traditional | 11/16/1979SE |
| K791541 | EMS Adapter Model 9160GEI · Traditional | 10/22/1979SE |
| K791494 | Vacutome Suction Unit · Traditional | 09/07/1979SE |
| K791000 | Vitreous Suction/CutterHKP · Traditional | 09/04/1979SE |
| K791468 | Resusci-Bag-ValveBTM · Traditional | 08/22/1979SE |
| K791230 | Electrosurgical Generator (Tim)GEI · Traditional | 08/16/1979SE |
| K791001 | Penlight/Swab HolderKYT · Traditional | 06/22/1979SE |
| K790367 | Grab-ItGEI · Traditional | 03/02/1979SE |
| K790135 | Monitor, PressurveilDSK · Traditional | 02/13/1979SE |
| K781960 | Surgical Eye ShieldHJK · Traditional | 02/09/1979SE |
| K782046 | C-CordFFZ · Traditional | 01/10/1979SE |
| K771785 | Irrigating Needle, Illuminated · Traditional | 11/29/1977SE |
| K771732 | Thornton Anterior Chamber IrrigatorGBQ · Traditional | 09/28/1977SE |
| K771416 | Irrigation/Aspiration NeedleHMX · Traditional | 09/12/1977SE |
| K771554 | Suture Retention ClampKGS · Traditional | 09/02/1977SE |
| K770163 | Suture CutterJOK · Traditional | 03/30/1977SE |
| K770222 | Iris RetractorHNI · Traditional | 02/17/1977SE |
| K770194 | Naso-Lacrimal Duct InsertHNL · Traditional | 02/14/1977SE |
| K761353 | Viterous Suction CutterHKP · Traditional | 01/05/1977SE |
| K761352 | Dental Stain RemoverEFW · Traditional | 01/03/1977SE |
| K761249 | Radio Transparent ECG ElectrodeDRX · Traditional | 12/21/1976SE |
PMA approvals
- P770005 Hunter-Sessions Vena-Cava Occluder · 12/19/1977 · 0 supplements