Company ยท US
O.R. Concepts, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1994. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 9 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 7 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 |
| FGS | Carrier, Sponge, Endoscopic | 1 |
| GBZ | Catheter, Cholangiography | 1 |
| GCI | Laryngoscope, Endoscope | 1 |
| HIF | Insufflator, Laparoscopic | 1 |
| HIG | Insufflator, Hysteroscopic | 1 |
| HQZ | Frame, Spectacle | 1 |
| KDC | Instrument, Surgical, Disposable | 1 |
| KGX | Tape And Bandage, Adhesive | 1 |
| KME | Bedding, Disposable, Medical | 1 |
| MDM | Instrument, Manual, Surgical, General Use | 1 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 17, 1994 | K941337 | FLOWGUN ELECTROCAUTERY PROBES O.R. Concepts, Inc. | GEI |
| May 16, 1994 | K935971 | FLOWGUN ELECTROCAUTERY PROBES O.R. Concepts, Inc. | GEI |
| May 16, 1994 | K935970 | FLOWGUN ELECTROCAUTERY PROBE HANDLE O.R. Concepts, Inc. | GEI |
| Mar 7, 1994 | K935645 | FLOWGUN REUSABLE IRRIGATION PROBES O.R. Concepts, Inc. | GCJ |
| Oct 15, 1993 | K926242 | ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE O.R. Concepts, Inc. | GEI |
| Sep 24, 1993 | K922244 | INSUFFLATOR TUBING/FILTER KIT O.R. Concepts, Inc. | HIF |
| Sep 24, 1993 | K922197 | INSUFFLATOR TUBING KIT O.R. Concepts, Inc. | HIG |
| Aug 11, 1993 | K932449 | DR. FOG O.R. Concepts, Inc. | OCT |
| Jun 25, 1993 | K925147 | ORC 10.0MM SUCTION PROBE O.R. Concepts, Inc. | GCJ |
| May 21, 1993 | K925024 | ORC TAPPERED IRRIGATING PROBE O.R. Concepts, Inc. | GCY |
| May 17, 1993 | K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE O.R. Concepts, Inc. | GCY |
| Apr 7, 1993 | K923818 | O.R. CONCEPTS' IRRIGATING KITTNER O.R. Concepts, Inc. | FGS |
| Mar 18, 1993 | K924022 | O.R. CONCEPTS SECONDARY CANNULA O.R. Concepts, Inc. | GCJ |
| Feb 17, 1993 | K930399 | ORC ENDOSCOPIC INSTRUMENT HOLDER O.R. Concepts, Inc. | MDM |
| Nov 20, 1992 | K923416 | O.R. CONCEPTS' ELECTROSURGICAL PROBE O.R. Concepts, Inc. | GEI |
| Nov 20, 1992 | K923199 | O.R. CONCEPTS ELECTROSURGICAL PROBES O.R. Concepts, Inc. | GEI |
| Sep 11, 1992 | K924264 | O.R. CONCEPTS CABLE HARNESS O.R. Concepts, Inc. | GEI |
| Aug 14, 1992 | K922405 | O.R.C. ADAPTER O.R. Concepts, Inc. | GCJ |
| May 6, 1992 | K920643 | LAPAROSCOPIC SUCTION/IRRIGATION PROBE O.R. Concepts, Inc. | GBZ |
| Mar 19, 1992 | K915057 | CANN-HOLD O.R. Concepts, Inc. | KGX |
| Mar 18, 1992 | K915854 | ENDOSCOPIC TRANSLUMINATOR O.R. Concepts, Inc. | GCJ |
| Mar 13, 1992 | K915762 | POOLE TIP SUCTION PROBE O.R. Concepts, Inc. | GCI |
| Feb 28, 1992 | K914960 | INSTRUMENT ORGANIZER O.R. Concepts, Inc. | KDC |
| Jan 9, 1992 | K915214 | ARTHROSCOPY CAMERA DRAPE O.R. Concepts, Inc. | KKX |
| Dec 9, 1991 | K914782 | SUCTION/IRRIGATION PROBE O.R. Concepts, Inc. | GCJ |
| Dec 9, 1991 | K914781 | SUCTION/IRRIGATION KITTNER O.R. Concepts, Inc. | GCJ |
| Oct 30, 1991 | K914377 | TROCAR O.R. Concepts, Inc. | GCJ |
| Sep 25, 1991 | K913500 | CHERRY SPONGE O.R. Concepts, Inc. | GCJ |
| Jun 1, 1989 | K893212 | THERMALAP O.R. Concepts, Inc. | KKX |
| Sep 3, 1986 | K863182 | EYE BARRIER O.R. Concepts, Inc. | HQZ |
| Feb 19, 1986 | K860066 | REFLECTIVE BLANKET O.R. Concepts, Inc. | KME |
| Feb 7, 1986 | K860065 | SLUSH PAN COVER O.R. Concepts, Inc. | |
| Jan 27, 1986 | K860068 | FOOT PEDAL COVER O.R. Concepts, Inc. | |
| Jan 27, 1986 | K860067 | MICROSCOPE COLUMN DRAPE O.R. Concepts, Inc. |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||