O.R. Concepts, Inc.
Irving, TX, US
O.R. Concepts, Inc. appears in FDA device records in Irving, TX. FDA records list 34 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 34
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 34 510(k) clearances for O.R. Concepts, Inc. between 1986 and 1994. The busiest year on record is 1992, with 10. The most recent is 1994, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 5 |
| 1989 | 1 |
| 1991 | 4 |
| 1992 | 10 |
| 1993 | 10 |
| 1994 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K941337 | FLOWGUN ELECTROCAUTERY PROBES | GEI | Substantially Equivalent | |
| K935971 | FLOWGUN ELECTROCAUTERY PROBES | GEI | Substantially Equivalent | |
| K935970 | FLOWGUN ELECTROCAUTERY PROBE HANDLE | GEI | Substantially Equivalent | |
| K935645 | FLOWGUN REUSABLE IRRIGATION PROBES | GCJ | Substantially Equivalent | |
| K926242 | ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE | GEI | Substantially Equivalent | |
| K922244 | INSUFFLATOR TUBING/FILTER KIT | HIF | Substantially Equivalent | |
| K922197 | INSUFFLATOR TUBING KIT | HIG | Substantially Equivalent | |
| K932449 | DR. FOG | OCT | Substantially Equivalent | |
| K925147 | ORC 10.0MM SUCTION PROBE | GCJ | Substantially Equivalent | |
| K925024 | ORC TAPPERED IRRIGATING PROBE | GCY | Substantially Equivalent | |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | GCY | Substantially Equivalent | |
| K923818 | O.R. CONCEPTS' IRRIGATING KITTNER | FGS | Substantially Equivalent | |
| K924022 | O.R. CONCEPTS SECONDARY CANNULA | GCJ | Substantially Equivalent | |
| K930399 | ORC ENDOSCOPIC INSTRUMENT HOLDER | MDM | Substantially Equivalent | |
| K923416 | O.R. CONCEPTS' ELECTROSURGICAL PROBE | GEI | Substantially Equivalent | |
| K923199 | O.R. CONCEPTS ELECTROSURGICAL PROBES | GEI | Substantially Equivalent | |
| K924264 | O.R. CONCEPTS CABLE HARNESS | GEI | Substantially Equivalent | |
| K922405 | O.R.C. ADAPTER | GCJ | Substantially Equivalent | |
| K920643 | LAPAROSCOPIC SUCTION/IRRIGATION PROBE | GBZ | Substantially Equivalent | |
| K915057 | CANN-HOLD | KGX | Substantially Equivalent | |
| K915854 | ENDOSCOPIC TRANSLUMINATOR | GCJ | Substantially Equivalent | |
| K915762 | POOLE TIP SUCTION PROBE | GCI | Substantially Equivalent | |
| K914960 | INSTRUMENT ORGANIZER | KDC | Substantially Equivalent | |
| K915214 | ARTHROSCOPY CAMERA DRAPE | KKX | Substantially Equivalent | |
| K914782 | SUCTION/IRRIGATION PROBE | GCJ | Substantially Equivalent | |
| K914781 | SUCTION/IRRIGATION KITTNER | GCJ | Substantially Equivalent | |
| K914377 | TROCAR | GCJ | Substantially Equivalent | |
| K913500 | CHERRY SPONGE | GCJ | Substantially Equivalent | |
| K893212 | THERMALAP | KKX | Substantially Equivalent | |
| K863182 | EYE BARRIER | HQZ | Substantially Equivalent | |
| K860066 | REFLECTIVE BLANKET | KME | Substantially Equivalent | |
| K860065 | SLUSH PAN COVER | Substantially Equivalent | ||
| K860068 | FOOT PEDAL COVER | Substantially Equivalent | ||
| K860067 | MICROSCOPE COLUMN DRAPE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- OCTAnti Fog Solution And Accessories, Endoscopy
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KMEBedding, Disposable, Medical
- FGSCarrier, Sponge, Endoscopic
- GBZCatheter, Cholangiography
- KKXDrape, Surgical, Antimicrobial
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HQZFrame, Spectacle
- MDMInstrument, Manual, Surgical, General Use
- KDCInstrument, Surgical, Disposable
- HIGInsufflator, Hysteroscopic
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- GCILaryngoscope, Endoscope
- KGXTape And Bandage, Adhesive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain