FDA.reportPublic FDA data

Medtronic Neurosurgery

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155315293015531529Medtronic Neurosurgery1N2026-01-014620 North Beach Street Fort Worth TX US 76137
20218982021898MEDTRONIC NEUROSURGERY1Y2020-04-25125 CREMONA DR. Goleta CA US 93117

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
776261187727372K994158MACROSORBOS PROTECTIVE SHEETHRS2000-07-24
2377331187727372K994158MACROSORBOS PROTECTIVE SHEETHRS2000-07-24
776261754960823K991502MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022JXG2000-09-12
2377331754960823K991502MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022JXG2000-09-12
776261815608927K990333MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015GWG1999-04-28
2377331815608927K990333MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015GWG1999-04-28
776261810442292K984053BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMJXG1999-02-04
2377331810442292K984053BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMJXG1999-02-04
776261577748025K983799MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICLGWM1999-01-26
2377331577748025K983799MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICLGWM1999-01-26
776261820043919K983360MACROPORE PROTECTIVE SHEETJEY1999-03-19
2377331820043919K983360MACROPORE PROTECTIVE SHEETJEY1999-03-19
776261335786836K983331MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102HCA1998-12-16
2377331335786836K983331MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102HCA1998-12-16
776261962449088K981046MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118JXG1998-06-16
2377331962449088K981046MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118JXG1998-06-16
776261115633591K974017TIMESH SYSTEMHRS1998-01-16
2377331115633591K974017TIMESH SYSTEMHRS1998-01-16
776262032410726K973145TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEMJEY1997-11-19
2377332032410726K973145TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEMJEY1997-11-19
776261421945481K972913MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)HRS1998-07-30
2377331421945481K972913MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)HRS1998-07-30
776261262549034K960915CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXXGWG1996-12-24
2377331262549034K960915CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXXGWG1996-12-24
776261810249984K955598CLARUS SPINEPEN MODEL 2126GWG1996-02-06
2377331810249984K955598CLARUS SPINEPEN MODEL 2126GWG1996-02-06
776261744766146K951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KITJXG1995-09-18
2377331744766146K951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KITJXG1995-09-18
776261008153435K945633NEURO CHANNEL ENDOSCOPE MODEL 2232GWG1995-09-19
2377331008153435K945633NEURO CHANNEL ENDOSCOPE MODEL 2232GWG1995-09-19
776261702885810K942249CLARUS NEUROPEN MODEL 2120GWG1994-11-04
2377331702885810K942249CLARUS NEUROPEN MODEL 2120GWG1994-11-04
776261290938709K940096PS MEDICAL CATHETER PLACEMENT KITGWG1994-05-03
2377331290938709K940096PS MEDICAL CATHETER PLACEMENT KITGWG1994-05-03
776261512214761K934545PS MEDICAL DELTA BURR HOLE VALVEJXG1994-04-28
2377331512214761K934545PS MEDICAL DELTA BURR HOLE VALVEJXG1994-04-28
776261639685261K934167IPI DUAL LUMEN PORTLJT1994-07-14
2377331639685261K934167IPI DUAL LUMEN PORTLJT1994-07-14
776261234987349K930606PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERGYK1993-09-10
2377331234987349K930606PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERGYK1993-09-10
776261693186906K923802TIMESH TITANIUM MINI-SOFTPLATE/SCREWJEY1992-10-26
2377331693186906K923802TIMESH TITANIUM MINI-SOFTPLATE/SCREWJEY1992-10-26
776261813425603K923419TISMESH SYSTEMJEY1993-04-08
2377331813425603K923419TISMESH SYSTEMJEY1993-04-08
776261034499069K922308TILGHMAN TITANIUM MESH SKELETAL ORBIT LINERFTM1993-01-12
2377331034499069K922308TILGHMAN TITANIUM MESH SKELETAL ORBIT LINERFTM1993-01-12
776261278305171K915546PS MEDICAL VENTRICULOSTOMY KITHBG1991-12-30
2377331278305171K915546PS MEDICAL VENTRICULOSTOMY KITHBG1991-12-30
776261176277912K913412PS MEDICAL CSF-ACCESS DEVICEJXG1993-03-30
2377331176277912K913412PS MEDICAL CSF-ACCESS DEVICEJXG1993-03-30
776261243118655K912447SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200FET1991-09-27
2377331243118655K912447SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200FET1991-09-27
776261833215824K911410PS MEDICAL BUTTON VALVEJXG1991-06-28
2377331833215824K911410PS MEDICAL BUTTON VALVEJXG1991-06-28
776261984373529K911382IPI ALGO-LINE CATHETERMAJ1991-07-18
2377331984373529K911382IPI ALGO-LINE CATHETERMAJ1991-07-18
776261114078981K904283PS MEDICAL CRANIAL HAND DRILLHBG1990-10-03
2377331114078981K904283PS MEDICAL CRANIAL HAND DRILLHBG1990-10-03
776261057631101K902783PS MEDICAL DELTA CSF-FLOW CONTROL VALVEJXG1990-08-08
2377331057631101K902783PS MEDICAL DELTA CSF-FLOW CONTROL VALVEJXG1990-08-08
776261248861798K896723CLIP GUN WITH RANEY TYPE SCALP CLIPSHBO1990-03-23
2377331248861798K896723CLIP GUN WITH RANEY TYPE SCALP CLIPSHBO1990-03-23
776261814456844K896167PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIRJXG1989-12-21
2377331814456844K896167PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIRJXG1989-12-21
776261740226822K874498CSF-VENTRICULOSTOMY RESERVOIRLKG1988-02-11
2377331740226822K874498CSF-VENTRICULOSTOMY RESERVOIRLKG1988-02-11
776261289533038K874468P-S MEDICAL VENTRICULAR ACCESS PORTLKG1988-02-11
2377331289533038K874468P-S MEDICAL VENTRICULAR ACCESS PORTLKG1988-02-11
776261058732856K873247CSF-FLOW CONTROL VALVE, ULTRA SMALLJXG1987-09-18
2377331058732856K873247CSF-FLOW CONTROL VALVE, ULTRA SMALLJXG1987-09-18
776261848707888K871752CSF-CARDIAC/PERITONEAL CATHETERJXG1987-05-22
2377331848707888K871752CSF-CARDIAC/PERITONEAL CATHETERJXG1987-05-22
776261571223715K862907P-S MEDICAL CSF-SIPHON CONTROL DEVICEJXG1986-12-03
2377331571223715K862907P-S MEDICAL CSF-SIPHON CONTROL DEVICEJXG1986-12-03
776261343366673K862303BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.JXG1986-08-12
2377331343366673K862303BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.JXG1986-08-12
776261659147415K841442P-S MEDICAL CSF-FLOW CONTROL VALVE-JXG1984-04-19
2377331659147415K841442P-S MEDICAL CSF-FLOW CONTROL VALVE-JXG1984-04-19
776261200197608K833822P-S MEDICAL CSF ACCESS DEV 15MM/25MMLKG1984-05-25
2377331200197608K833822P-S MEDICAL CSF ACCESS DEV 15MM/25MMLKG1984-05-25
776261190702995K831678P-S MEDICAL CSF-FLOW CONTROL VALVE-BURJXG1983-06-24
2377331190702995K831678P-S MEDICAL CSF-FLOW CONTROL VALVE-BURJXG1983-06-24
776261726553611K831396P-S MEDICAL CSF-LUMBOPERITONEAL SHUNTJXG1983-08-12
2377331726553611K831396P-S MEDICAL CSF-LUMBOPERITONEAL SHUNTJXG1983-08-12
776261228801547K823509P-S MED. LUMBO PERITONEAL & VENTRICULO-JXG1982-12-16
2377331228801547K823509P-S MED. LUMBO PERITONEAL & VENTRICULO-JXG1982-12-16
776262044465882K823503P-S CSF-VENTRICULAR CATHETER, FLANGEDJXG1983-03-09
2377332044465882K823503P-S CSF-VENTRICULAR CATHETER, FLANGEDJXG1983-03-09
776261122760541K803257CSG-FLOW CONTROL VALVEJXG1981-01-22
2377331122760541K803257CSG-FLOW CONTROL VALVEJXG1981-01-22
776261965347160K802100INTRACRANIAL PRESSURING MONITORING SYST.GWM1980-09-16
2377331965347160K802100INTRACRANIAL PRESSURING MONITORING SYST.GWM1980-09-16
776261733433309K792007CSF-VENTRICULAR CATHETER, STANDARD DESJXG1980-01-16
2377331733433309K792007CSF-VENTRICULAR CATHETER, STANDARD DESJXG1980-01-16
776261671711038K792005CSF-CARDIAC/PERITONEAL CATHETERJXG1980-01-16
2377331671711038K792005CSF-CARDIAC/PERITONEAL CATHETERJXG1980-01-16
2377331408244694K243676Duet External Drainage and Monitoring System (EDMS)JXG2025-03-10
2377331557396390K242034Duet External Drainage and Monitoring System (EDMS)PCB2024-10-24
2377331797923992K212641StrataMR II Valves and ShuntsJXG2021-09-16
2377331843348100K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser LevelGWM2020-05-26
2377331893465172K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage BagsGWM2020-04-09
2377331642934502K200456Becker External Drainage and Monitoring SystemGWM2020-03-26
776261111108831K181622StrataMR guider toolJXG2018-10-01
2377331111108831K181622StrataMR guider toolJXG2018-10-01
776261494373024K152700StrataMR Valves and ShuntsJXG2016-04-07
2377331494373024K152700StrataMR Valves and ShuntsJXG2016-04-07
776261836573053K123524MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMJXG2013-02-13
2377331836573053K123524MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMJXG2013-02-13
776261004329947K110560MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETERJXG2011-11-18
2377331004329947K110560MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETERJXG2011-11-18
776262043856160K091312PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMJXG2009-09-02
2377332043856160K091312PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEMJXG2009-09-02
776261365896107K083076STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836JXG2008-11-20
2377331365896107K083076STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836JXG2008-11-20
776261791244126K082127STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635JXG2008-08-27
2377331791244126K082127STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635JXG2008-08-27
776261065877097K073139SMALL LUMEN PERITONEAL CATHETERJXG2008-01-30
2377331065877097K073139SMALL LUMEN PERITONEAL CATHETERJXG2008-01-30
776261935302580K063836RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715JXG2007-08-16
2377331935302580K063836RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715JXG2007-08-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG762025-03-10
GWG182001-04-20
JEY142001-09-18
GWM72020-05-26
GXQ62006-11-03
HBG62002-11-12
HRS62000-07-24
LKG61988-02-11
HBO42005-02-07
PCB32024-10-24
HWC22006-09-08
GXR22001-05-07
GEI22001-05-03
MQN22000-06-26
HCA21998-12-16
LJT21994-07-14
GYK21993-09-10
FTM21993-01-12
FET21991-09-27
MAJ21991-07-18

PMN#