Karl Storz Endoscopy

FDA Regulatory Profile

Summary

Total Recalls
70
510(k) Clearances
35
Inspections
4
Compliance Actions
0

Known Names

karl storz endoscopy, karl storz endoscopy-america

Recent Recalls

NumberClassProductDate
Z-1063-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123December 19, 2024
Z-1061-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27000K, Ureteroscope, 7 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123December 19, 2024
Z-1054-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27002KP, Pediatric Uretero-Renoscope 7.3 Fr., NON STERILE, CE 0123December 19, 2024
Z-1059-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27002L, Uretero-Renoscope, 9.5 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CEDecember 19, 2024
Z-1055-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123December 19, 2024
Z-1052-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CEDecember 19, 2024
Z-0837-2025Class IIKarl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CEDecember 19, 2024
Z-1062-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27001K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123December 19, 2024
Z-1056-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 01December 19, 2024
Z-1057-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27001L, Uretero-Renoscope, 8 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0December 19, 2024
Z-1060-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27010K, Ureteroscope, 7 Fr., 34 cm, NON STERILE, RxONLY, CE 0123December 19, 2024
Z-1064-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27011K, Ureteroscope, 8 Fr., 6¿, 34cm, CE 0123December 19, 2024
Z-1051-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123December 19, 2024
Z-1053-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CEDecember 19, 2024
Z-1058-2025Class IIKARL STORZ - ENDOSKOPE, REF: 27011L, Uretero-Renoscope, 8 Fr., 6¿, 43cm, NON STERILE, RxONLY, CE 01December 19, 2024
Z-0363-2025Class IIIrrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PCOctober 21, 2024
Z-0526-2025Class II4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius ResOctober 11, 2024
Z-3222-2024Class IIKarl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123July 23, 2024
Z-3221-2024Class IIKarl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123July 23, 2024
Z-3225-2024Class IIKarl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123July 23, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K043375FISCH TITANIUM MIDDLE EAR PROSTHESESJanuary 24, 2005
K030848PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIXJune 2, 2003
K030009KSEA POWERSHAVER SYSTEM S2April 2, 2003
K023924AUTOCON II 200 ELECTROSURGICAL GENERATORFebruary 21, 2003
K023187KSEA SPINOSCOPEDecember 2, 2002
K011700MODULITH SLK LITHOTRIPTERAugust 16, 2002
K021776KSEA QUADRO SWITCHAugust 15, 2002
K013107BIOABSORBABLE INTERFERENCE SCREW MEGAFIXFebruary 26, 2002
K011841KSEA SAWAHLE ELECTROMECHANICAL MORCELLATORSeptember 10, 2001
K010569KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMPApril 9, 2001
K004037X-RAY SYSTEM XR-MXFebruary 2, 2001
K001630KSEA BIPOLAR COAGULATING ELECTRODESJuly 19, 2000
K992469KSEA SCBCOMOctober 15, 1999
K992027KONINCKX UTERINE MANIPULATOR, KECKSTEIN-SCHIFF UTERINE MANIPULATOR, CLERMONT UTERINE MANIPULATORSeptember 9, 1999
K992541LAPAROCAMAugust 19, 1999
K992114KSEA CALCUSPLITAugust 18, 1999
K991228DCI ENDOSCOPEJune 23, 1999
K991171DCI ENDOSCOPEJune 23, 1999
K990411MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPEMay 11, 1999
K983142KSEA C-MOUNT ARTHROSCOPESDecember 7, 1998