O.R. Concepts, Inc.
Medical device manufacturer in Burnsville, MN.
34510(k) clearances
0PMA approvals
0recalls
Device types
- GCJ Laparoscope, General & Plastic Surgery 9
- GEI Electrosurgical, Cutting & Coagulation &… 7
- KKX Drape, Surgical, Antimicrobial 2
- GCY Apparatus, Suction, Single Patient Use… 2
- KME Bedding, Disposable, Medical 1
- HQZ Frame, Spectacle 1
- KDC Instrument, Surgical, Disposable 1
- GCI Laryngoscope, Endoscope 1
- KGX Tape And Bandage, Adhesive 1
- GBZ Catheter, Cholangiography 1
- MDM Instrument, Manual, Surgical, General Use 1
- FGS Carrier, Sponge, Endoscopic 1
- OCT Anti Fog Solution And Accessories, Endoscopy 1
- HIG Insufflator, Hysteroscopic 1
- HIF Insufflator, Laparoscopic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K941337 | Flowgun Electrocautery ProbesGEI · Traditional | 08/17/1994SE |
| K935971 | Flowgun Electrocautery ProbesGEI · Traditional | 05/16/1994SE |
| K935970 | Flowgun Electrocautery Probe HandleGEI · Traditional | 05/16/1994SE |
| K935645 | Flowgun Reusable Irrigation ProbesGCJ · Traditional | 03/07/1994SE |
| K926242 | Orc Endoscopic Monopolar Electrosurgical ProbeGEI · Traditional | 10/15/1993SE |
| K922244 | Insufflator Tubing/Filter KitHIF · Traditional | 09/24/1993SE |
| K922197 | Insufflator Tubing KitHIG · Traditional | 09/24/1993SE |
| K932449 | Dr. FogOCT · Traditional | 08/11/1993SE |
| K925147 | Orc 10.0MM Suction ProbeGCJ · Traditional | 06/25/1993SE |
| K925024 | Orc Tappered Irrigating ProbeGCY · Traditional | 05/21/1993SE |
| K923908 | # 9455 and #9457 Poole Tip Suction ProbeGCY · Traditional | 05/17/1993SE |
| K923818 | O.R. Concepts' Irrigating KittnerFGS · Traditional | 04/07/1993SE |
| K924022 | O.R. Concepts Secondary CannulaGCJ · Traditional | 03/18/1993SE |
| K930399 | Orc Endoscopic Instrument HolderMDM · Traditional | 02/17/1993SE |
| K923416 | O.R. Concepts' Electrosurgical ProbeGEI · Traditional | 11/20/1992SE |
| K923199 | O.R. Concepts Electrosurgical ProbesGEI · Traditional | 11/20/1992SE |
| K924264 | O.R. Concepts Cable HarnessGEI · Traditional | 09/11/1992SE |
| K922405 | O.R.C. AdapterGCJ · Traditional | 08/14/1992SE |
| K920643 | Laparoscopic Suction/Irrigation ProbeGBZ · Traditional | 05/06/1992SE |
| K915057 | Cann-HoldKGX · Traditional | 03/19/1992SE |
| K915854 | Endoscopic TransluminatorGCJ · Traditional | 03/18/1992SE |
| K915762 | Poole Tip Suction ProbeGCI · Traditional | 03/13/1992SE |
| K914960 | Instrument OrganizerKDC · Traditional | 02/28/1992SE |
| K915214 | Arthroscopy Camera DrapeKKX · Traditional | 01/09/1992SE |
| K914782 | Suction/Irrigation ProbeGCJ · Traditional | 12/09/1991SE |
| K914781 | Suction/Irrigation KittnerGCJ · Traditional | 12/09/1991SE |
| K914377 | TrocarGCJ · Traditional | 10/30/1991SE |
| K913500 | Cherry SpongeGCJ · Traditional | 09/25/1991SE |
| K893212 | ThermalapKKX · Traditional | 06/01/1989SE |
| K863182 | Eye BarrierHQZ · Traditional | 09/03/1986SE |
| K860066 | Reflective BlanketKME · Traditional | 02/19/1986SE |
| K860065 | Slush Pan Cover · Traditional | 02/07/1986SE |
| K860068 | Foot Pedal Cover · Traditional | 01/27/1986SE |
| K860067 | Microscope Column Drape · Traditional | 01/27/1986SE |