510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Concept, Inc.

Mchenry, IL, US

Concept, Inc. appears in FDA device records in Mchenry, IL. FDA records list 83 510(k) clearances between and , one PMA record and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
83
PMA records
1
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 83

FDA records hold 83 510(k) clearances for Concept, Inc. between 1976 and 1992. The busiest year on record is 1983, with 14. The most recent is 1992, with 1.

Clearances by year, as a table
510(k) clearance decisions for Concept, Inc., by decision year
YearClearances
19761
19779
197912
19804
19811
19823
198314
19848
19858
19864
19877
19886
19893
19901
19911
19921
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K912640CONCEPT ENDOSTEAL FIXATION DEVICEHWCSubstantially Equivalent
K912957CONCEPT MICROMILLHRXSubstantially Equivalent
K896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMHSXSubstantially Equivalent for Some Indications
K894929STAPLE FIXATION SYSTEMJDRSubstantially Equivalent
K892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)HRXSubstantially Equivalent
K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBEKNTSubstantially Equivalent
K881954CONCEPT POWER SYSTEMHSZSubstantially Equivalent
K884255CONCEPT CCT-5200, THERMAL THERAPY SYSTEMILOSubstantially Equivalent
K882121C-FLO SUCTION TUBEDXQSubstantially Equivalent
K880414TENDON HARVESTERHRXSubstantially Equivalent
K874676INTERFERENCE SCREWHWCSubstantially Equivalent
K880413PATELLAR TENDON GRAFT GUIDELXHSubstantially Equivalent
K874515CONCEPT SUTURE NEEDLEHRXSubstantially Equivalent
K874439SOFT TISSUE ANCHORING SET KITLROSubstantially Equivalent
K873030CONCEPT ARTHROSCOPIC PORTAL RODHRXSubstantially Equivalent
K872608HEWSON A.C.L. GUIDE SETKGSSubstantially Equivalent
K873009CONCEPT SWITCHING STICKKGZSubstantially Equivalent
K872156CONCEPT SELF COMPRESSING CANNULATED SCREW SYSTEMHWCSubstantially Equivalent
K871037CANCELLOUS FIXATION SCREW & WASHER FOR USE W/SCREWHWCSubstantially Equivalent
K863396CONCEPT INTRAVISION ARTHROSCOPE SYSTEMHRXSubstantially Equivalent
K862659CONCEPT ARTHROSCOPY RASPHTPSubstantially Equivalent
K862658CONCEPT ARTHROSCOPIC KNIFEHRXSubstantially Equivalent
K862657CONCEPT CURETTEHRXSubstantially Equivalent
K853829MENISCAL REPAIR SYSTEMSubstantially Equivalent
K851040CONCEPT DEFRERE ELECTRODEGEISubstantially Equivalent
K851339PRECISION HARVEST & INLAY INSTRUMENT SETHWKSubstantially Equivalent
K850749CONCEPT VIDEO IMAGING SYSTEMKQMSubstantially Equivalent
K850423CONCEPT SUCTION SLEEVEHTZSubstantially Equivalent
K850714C.A.D. PACK I -ARTHROSCOPY DRAPE PACKSubstantially Equivalent
K850645INTRA-ARC DISPOSABLE ARTHROPLASTY BURRSSubstantially Equivalent
K850462CONCEPT CAMERA DRAPESubstantially Equivalent
K843925GILL'S IRRIGATOR/ASPIRATOR NEEDLEGAASubstantially Equivalent
K842710CONCEPT C-VACGCYSubstantially Equivalent
K841483ALL PURPOSE ELECTROSURGICAL GENERATORGEISubstantially Equivalent
K843491CONCEPT FIBER OPTIC CANALICULUS INTUBAHNLSubstantially Equivalent
K843490TUBE-STATBSRSubstantially Equivalent
K840558SHUTT PRECISION PROBESHXBSubstantially Equivalent
K833856C-LOOPSSubstantially Equivalent
K834069ARTHROSCAN VIDEO SYSTEMFWFSubstantially Equivalent
K833940TORQUE PLUS CATALOG 30120HWESubstantially Equivalent
K833441DRY GELGEISubstantially Equivalent
K833624SHUTT UNIVERSAL STRESS POSTFWZSubstantially Equivalent
K833076C-FLEX MEDICAL GRADE TUBINGFPKSubstantially Equivalent
K833061C-FLEX PENROSE DRAINAGE TUBEFFASubstantially Equivalent
K832362DONALDSON-TYPE VENT TUBEETDSubstantially Equivalent
K832361CONCEPT T-TUBEETDSubstantially Equivalent
K830800C-LOOPSKDCSubstantially Equivalent
K832278LIGHT HANDLE COVERKKXSubstantially Equivalent
K832293ENTERNAL FEEDING TUBEKNTSubstantially Equivalent
K830434DISPOSABLE INTRA-ARTICULAR BLADEGFASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain