Company ยท US
Concept, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1992. Name variants (Inc, Corp, punctuation) are merged.
83510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 10 |
| HRX | Arthroscope | 10 |
| HWC | Screw, Fixation, Bone | 4 |
| HNL | Probe, Lachrymal | 3 |
| ETD | Tube, Tympanostomy | 2 |
| HKP | Instrument, Vitreous Aspiration And Cutting, Battery-Powered | 2 |
| KGS | Retention Device, Suture | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 |
| BSR | Stylet, Tracheal Tube | 1 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| DRX | Electrode, Electrocardiograph | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DXQ | Blood Pressure Cuff | 1 |
| EFW | Toothbrush, Manual | 1 |
| FFA | Tube, Drainage, Suprapubic | 1 |
| FFZ | Cord, Electric, For Endoscope | 1 |
| FPK | Tubing, Fluid Delivery | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 |
| FWH | Camera, Cine, Surgical, Without Audio | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 1992 | K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE Concept, Inc. | HWC |
| Oct 4, 1991 | K912957 | CONCEPT MICROMILL Concept, Inc. | HRX |
| Jun 5, 1990 | K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM Concept, Inc. | HSX |
| Aug 30, 1989 | K894929 | STAPLE FIXATION SYSTEM Concept, Inc. | JDR |
| Aug 1, 1989 | K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) Concept, Inc. | HRX |
| May 8, 1989 | K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE Concept, Inc. | KNT |
| Nov 9, 1988 | K881954 | CONCEPT POWER SYSTEM Concept, Inc. | HSZ |
| Nov 8, 1988 | K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM Concept, Inc. | ILO |
| Jun 20, 1988 | K882121 | C-FLO SUCTION TUBE Concept, Inc. | DXQ |
| Mar 25, 1988 | K880414 | TENDON HARVESTER Concept, Inc. | HRX |
| Mar 7, 1988 | K874676 | INTERFERENCE SCREW Concept, Inc. | HWC |
| Mar 4, 1988 | K880413 | PATELLAR TENDON GRAFT GUIDE Concept, Inc. | LXH |
| Nov 27, 1987 | K874515 | CONCEPT SUTURE NEEDLE Concept, Inc. | HRX |
| Nov 20, 1987 | K874439 | SOFT TISSUE ANCHORING SET KIT Concept, Inc. | LRO |
| Sep 16, 1987 | K873030 | CONCEPT ARTHROSCOPIC PORTAL ROD Concept, Inc. | HRX |
| Sep 16, 1987 | K872608 | HEWSON A.C.L. GUIDE SET Concept, Inc. | KGS |
| Aug 17, 1987 | K873009 | CONCEPT SWITCHING STICK Concept, Inc. | KGZ |
| Jul 21, 1987 | K872156 | CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEM Concept, Inc. | HWC |
| Mar 25, 1987 | K871037 | CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREW Concept, Inc. | HWC |
| Sep 12, 1986 | K863396 | CONCEPT INTRAVISION ARTHROSCOPE SYSTEM Concept, Inc. | HRX |
| Sep 2, 1986 | K862659 | CONCEPT ARTHROSCOPY RASP Concept, Inc. | HTP |
| Jul 23, 1986 | K862658 | CONCEPT ARTHROSCOPIC KNIFE Concept, Inc. | HRX |
| Jul 23, 1986 | K862657 | CONCEPT CURETTE Concept, Inc. | HRX |
| Oct 8, 1985 | K853829 | MENISCAL REPAIR SYSTEM Concept, Inc. | |
| Jul 11, 1985 | K851040 | CONCEPT DEFRERE ELECTRODE Concept, Inc. | GEI |
| Jul 2, 1985 | K851339 | PRECISION HARVEST & INLAY INSTRUMENT SET Concept, Inc. | HWK |
| May 20, 1985 | K850749 | CONCEPT VIDEO IMAGING SYSTEM Concept, Inc. | KQM |
| Mar 14, 1985 | K850423 | CONCEPT SUCTION SLEEVE Concept, Inc. | HTZ |
| Mar 6, 1985 | K850714 | C.A.D. PACK I -ARTHROSCOPY DRAPE PACK Concept, Inc. | |
| Mar 6, 1985 | K850645 | INTRA-ARC DISPOSABLE ARTHROPLASTY BURRS Concept, Inc. | |
| Feb 26, 1985 | K850462 | CONCEPT CAMERA DRAPE Concept, Inc. | |
| Nov 5, 1984 | K843925 | GILL'S IRRIGATOR/ASPIRATOR NEEDLE Concept, Inc. | GAA |
| Oct 31, 1984 | K842710 | CONCEPT C-VAC Concept, Inc. | GCY |
| Oct 23, 1984 | K841483 | ALL PURPOSE ELECTROSURGICAL GENERATOR Concept, Inc. | GEI |
| Oct 5, 1984 | K843491 | CONCEPT FIBER OPTIC CANALICULUS INTUBA Concept, Inc. | HNL |
| Oct 4, 1984 | K843490 | TUBE-STAT Concept, Inc. | BSR |
| Apr 25, 1984 | K840558 | SHUTT PRECISION PROBES Concept, Inc. | HXB |
| Feb 4, 1984 | K833856 | C-LOOPS Concept, Inc. | |
| Jan 27, 1984 | K834069 | ARTHROSCAN VIDEO SYSTEM Concept, Inc. | FWF |
| Dec 28, 1983 | K833940 | TORQUE PLUS CATALOG 30120 Concept, Inc. | HWE |
| Nov 29, 1983 | K833441 | DRY GEL Concept, Inc. | GEI |
| Nov 28, 1983 | K833624 | SHUTT UNIVERSAL STRESS POST Concept, Inc. | FWZ |
| Nov 21, 1983 | K833076 | C-FLEX MEDICAL GRADE TUBING Concept, Inc. | FPK |
| Nov 7, 1983 | K833061 | C-FLEX PENROSE DRAINAGE TUBE Concept, Inc. | FFA |
| Oct 14, 1983 | K832362 | DONALDSON-TYPE VENT TUBE Concept, Inc. | ETD |
| Oct 14, 1983 | K832361 | CONCEPT T-TUBE Concept, Inc. | ETD |
| Oct 4, 1983 | K830800 | C-LOOPS Concept, Inc. | KDC |
| Sep 29, 1983 | K832278 | LIGHT HANDLE COVER Concept, Inc. | KKX |
| Sep 12, 1983 | K832293 | ENTERNAL FEEDING TUBE Concept, Inc. | KNT |
| Apr 12, 1983 | K830434 | DISPOSABLE INTRA-ARTICULAR BLADE Concept, Inc. | GFA |
Newest 50 of 83.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||