FBO

Product Code: FBO


Products Classified as FBO

1738CystourethroscopeEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

1738CystourethroscopeEndoscope And Accessories.

FDA Consensus Standards

Cystourethroscope [32386]21 CFR §876.1500 🔎
Cystourethroscope [30564]21 CFR §876.1500 🔎
Cystourethroscope [30563]21 CFR §876.1500 🔎
Cystourethroscope [33513]21 CFR §876.1500 🔎
Cystourethroscope [36928]21 CFR §876.1500 🔎
Cystourethroscope [31951]21 CFR §876.1500 🔎

Pre-market Notifications for FBO

K131364FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPEKARL STORZ ENDOSCOPY-AMERICA, INC.
K082046KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCOKARL STORZ ENDOSCOPY-AMERICA, INC.
K080780ANCHORAGE SCOPE, MODEL 000003EPITEK, INC.
K062918KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEMKARL STORZ ENDOSCOPY-AMERICA, INC.
K061646LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIESLASERSCOPE
K011496CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660RICHARD WOLF MEDICAL INSTRUMENTS CORP.
K972979SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUMSMITH & NEPHEW, INC.
K962474OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY)OLYMPUS AMERICA, INC.
K951972CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSCABOT MEDICAL CORP.
K945185CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB)KARL STORZ ENDOSCOPY-AMERICA, INC.
K943668KSEA CONTINOUS FLOW CYSTOSCOPEKARL STORZ ENDOSCOPY-AMERICA, INC.
K941992CYSTOSCOPESURGICAL TECHNOLOGIES, INC.
K935163CONTINUOUS IRRIGATION CYSTOURETHROSCOPERICHARD WOLF MEDICAL INSTRUMENTS CORP.
K934649GALILEO ENDOSCOPESGALILEO ELECTRO-OPTICS CORP.
K904797SURGITEK GRADUATED CYSTOSCOPE (MODEL GC-16)SURGITEK

Global Unique Device Identification Database

00821925007772CYSTOURETHROSCOPE
00821925027275CYSTOURETHROSCOPE
00821925011229CYSTOURETHROSCOPE
00821925008243CYSTOURETHROSCOPE
00821925008229CYSTOURETHROSCOPE
00821925001947CYSTOURETHROSCOPE
00821925001916CYSTOURETHROSCOPE
00821925001374CYSTOURETHROSCOPE
04953170367809CYSTOURETHROSCOPE
04953170359958CYSTOURETHROSCOPE
04953170213489CYSTOURETHROSCOPE
04953170064623CYSTOURETHROSCOPE
04953170063909CYSTOURETHROSCOPE
04055207045688CYSTOURETHROSCOPE
04055207045671CYSTOURETHROSCOPE

Maude Adverse Events

INNER SHEATH WITH CERAMIC BEAKKARL STORZ SE & CO. KG2020-02-20
IGLESIAS WORKING ELEMENTGYRUS ACMI, INC2020-02-03
INNER SHEATH ONLYKARL STORZ SE & CO. KG2020-01-29
INNER SHEATH ONLYKARL STORZ SE & CO. KG2020-01-29
INNER SHEATHKARL STORZ SE & CO. KG2020-01-17
TUBE,INNER,CERAMIC INSULATIONKARL STORZ SE & CO. KG2019-10-16
INNER SHEATH WITH CERAMIC BEAKKARL STORZ SE & CO. KG2019-10-04
CYSTO-URETHRO-FIBERSCOPEKARL STORZ ENDOVISION2019-10-03
INNER TUBE WITH CERAMIC BEAKKARL STORZ SE & CO. KG2019-09-05
CYSTO-URETHRO-FIBERSCOPEKARL STORZ SE & CO. KG2019-08-28
PK FRONT LOAD,IGLESIAS,WORKING ELEMENTGYRUS ACMI, INC2019-08-20
INNER TUBE WITH CERAMIC BEAKKARL STORZ SE & CO. KG2019-07-15
KARL STORZ2019-07-01
INNER TUBE WITH CERAMIC BEAKKARL STORZ SE & CO. KG2019-06-28
TUBE,INNER,CERAMIC INSULATION.KARL STORZ SE & CO. KG2019-05-31
INNER SHEATH WITH CERAMIC BEAKKARL STORZ SE & CO. KG2019-03-02
PK FRONT LOAD,IGLESIAS,WORKING ELEMENTGYRUS ACMI, INC2019-02-24
IGLESIAS WORKING ELEMENTGYRUS ACMI, INC2019-01-24
IGLESIAS WORKING ELEMENTGYRUS ACMI, INC2018-07-06
IGLESIAS WORKING ELEMENTGYRUS ACMI, INC2018-07-06
INNER TUBE WITH CERAMIC BEAKKARL STORZ SE & CO. KG2018-06-22
OLYMPUS FLEXIBLE CYSTOSCOPE CYF-5OLYMPUS CORPORATION OF THE AMERICAS HEADQUARTERS2018-05-21
INNER TUBE WITH CERAMIC BEAKKARL STORZ SE & CO. KG2018-05-11
INNER TUBE WITH CERAMIC BEAKKARL STORZ GMBH CO. KG2018-04-13
FLEXIBLE VIDEO CYSTOSCOPEKARL STORZ ENDOVISION2018-04-10
FLEXIBLE VIDEO CYSTOSCOPEKARL STORZ ENDOVISION2018-04-10
FLEXIBLE VIDEO CYSTOSCOPEKARL STORZ ENDOVISION2018-04-10
INNER TUBE WITH CERAMIC BEAKKARL STORZ SE & CO. KG2018-03-07
INNER SHEATHKARL STORZ SE & CO. KG2018-03-01
CHOLEDOCHO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2017-12-03
IGLESIAS WORKING ELEMENTGYRUS ACMI, INC2017-11-15
USA ELITE SYSTEM ROTATING CF OUTER SHEATH, 25 FR, GOLDGYRUS ACMI, INC2017-11-14
N.A.KARL STORZ GMBH & CO. KG2017-09-21
IGLESIAS WORKING ELEMENTGYRUS ACMI, INC2017-07-24
IGLESIAS WORKING ELEMENTGYRUS ACMI, INC2017-07-21
IGLESIAS WORKING ELEMENTGYRUS ACMI, INC2017-07-12
TUBE, INNER ROTATABLE CERAMICKARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY2017-05-18
URETHROSCOPE SHEATHKARL STORZ ENDOSCOPY-AMERICA, INC.2017-04-11
TUBE, INNER ROTATABLE CERAMICKARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY2017-04-03
KARL STORZ CYSTOSCOPE SHEATH 20 FRENCH CYSTOURETHROSCOPEKARL STORZ2017-03-30
OES CHOLEDOCHOFIBERSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2017-03-10
FLEXIBLE FIBER-URETHRO-CYSTOSCOPERICHARD WOLF GMBH (GERMANY)2017-02-07
BIPOLAR RESECTOSCOPEOLYMPUS CORPORATION OF THE AMERICAS2016-11-08
FLEXIBLE VIDEO CYSTOSCOPEKARL STORZ ENDOVISION2016-08-29
FLEXIBLE VIDEO CYSTOSCOPEKARL STORZ ENDOVISION2016-08-29
FLEXIBLE VIDEO CYSTOSCOPEKARL STORZ ENDOVISION2016-08-29
11272CU1KARL STORZ ENDOVISION2016-08-12
11272CU1KARL STORZ ENDOVISION2016-08-12
11272CU1KARL STORZ ENDOVISION2016-08-12
CYSTYO-URETHROSCOPE SHEATHKARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY2016-04-21
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