FDA Product Code
FDA Product Code GWM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1620
510(k) Clearances — 105 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring System | Sophysa | 2026-04-10 | Traditional | PDF ↗ |
| K250285 | NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL | Raumedic AG | 2025-08-29 | Traditional | PDF ↗ |
| K240821 | B4C System - Addition of new sensor model (BcSs-PICNIW-2000) | Braincare Desenvolvimento E Inovação Tecnológica S.A. | 2024-07-18 | Traditional | PDF ↗ |
| K232890 | CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) | Integra Lifesciences Production Corporation | 2024-02-04 | Traditional | PDF ↗ |
| K201989 | B4C System | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2021-10-08 | Traditional | PDF ↗ |
| K210993 | CereLink ICP Monitor | Integra Lifesciences Production Corporation | 2021-04-30 | Special | PDF ↗ |
| K201118 | Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level | Medtronic, Inc. | 2020-05-26 | Special | PDF ↗ |
| K200630 | Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags | Medtronic, Inc. | 2020-04-09 | Special | PDF ↗ |
| K200456 | Becker External Drainage and Monitoring System | Medtronic, Inc. | 2020-03-26 | Special | PDF ↗ |
| K182073 | BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | 2019-10-17 | Traditional | PDF ↗ |
| K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable | Integra Lifesciences Corp. | 2019-01-11 | Special | PDF ↗ |
| K172209 | AURA ICP MONITORING SYSTEM | Branchpoint Technologies, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | Codman & Shurtleff, Inc. | 2017-11-08 | Special | PDF ↗ |
| K171666 | MPR2 logO DATALOGGER | Raumedic AG | 2017-07-06 | Traditional | PDF ↗ |
| K162108 | Pressio 2 ICP Monitoring System | Sophysa SA | 2017-04-17 | Traditional | PDF ↗ |
| K161010 | HICP200 Patient/Monitor Interconnect Cable | Innerspace Neuro Solutions, Inc. | 2016-10-20 | Traditional | PDF ↗ |
| K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit | Codman & Shurtleff, Inc. | 2016-08-19 | Traditional | PDF ↗ |
| K152670 | DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables | Medos International SARL | 2016-01-22 | Traditional | PDF ↗ |
| K141869 | QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT | Hemedex Incorporated | 2014-10-10 | Traditional | PDF ↗ |
| K133754 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER | Integra LifeSciences Corporation | 2014-03-06 | Traditional | PDF ↗ |
| K130529 | RAUMEDIC-PTO-MONITORING-SYSTEM | Raumedic AG | 2013-10-25 | Traditional | PDF ↗ |
| K131184 | INTEGRA LICOX PTO2 MONITOR | Integra Lifesciences Corp. | 2013-08-30 | Traditional | PDF ↗ |
| K121573 | INTEGRA CAMINO ICP MONITOR | Intrgra Lifesciences Corporation | 2012-09-10 | Traditional | PDF ↗ |
| K121159 | INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER | Integra Lifescience Corportation | 2012-07-20 | Traditional | PDF ↗ |
| K113088 | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) | Innerspace, Inc. | 2012-05-02 | Traditional | PDF ↗ |
| K120252 | RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM | Raumedic AG | 2012-04-11 | Traditional | PDF ↗ |
| K112017 | RAUMEDIC ICP MONITORING SYSTEM | Raumedic AG | 2011-10-11 | Traditional | PDF ↗ |
| K103206 | RAUMEDIC- ICP-MONITORING SYSTEM | Raumedic AG | 2011-03-04 | Traditional | PDF ↗ |
| K102077 | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | Cma Microdialysis AB | 2011-01-14 | Traditional | PDF ↗ |
| K102875 | CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C | Integra LifeSciences Corporation | 2010-12-20 | Traditional | PDF ↗ |
| K101133 | SENSOMETRICS SOFTWARE | Dpcom AS | 2010-11-18 | Traditional | PDF ↗ |
| K083378 | SYNERGY | Innerspace, Inc. | 2009-09-29 | Special | PDF ↗ |
| K071984 | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM | Cma Microdialysis AB | 2008-06-27 | Traditional | PDF ↗ |
| K072379 | MPS OXIPORT AND MPS OXIPORT PLUS | Innerspace, Inc. | 2008-04-29 | Special | PDF ↗ |
| K071505 | MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM | Integra LifeSciences Corporation | 2007-08-06 | Traditional | PDF ↗ |
| K062584 | PRESSIO ICP MONITORING SYSTEM | Sophysa SA | 2007-07-05 | Traditional | PDF ↗ |
| K061640 | INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM | Integra LifeSciences Corporation | 2006-07-27 | Traditional | PDF ↗ |
| K053244 | LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT | Integra Lifesciences Corp. | 2006-05-10 | Special | PDF ↗ |
| K060554 | CMA CEREBRAL TISSUE MONITORING SYSTEM | Cma Microdialysis AB | 2006-05-02 | Special | PDF ↗ |
| K051599 | NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT | Neurorecovery, Inc. | 2005-07-19 | Traditional | PDF ↗ |
| K050702 | NEUROSYSTEMS 1TM MONITOR | Neurosystems, LLC | 2005-05-17 | Traditional | PDF ↗ |
| K050720 | NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 | Integra Neurosciences | 2005-05-11 | Special | PDF ↗ |
| K041838 | MPS (OR MPS-T) | Innerspace, Inc. | 2005-03-01 | Traditional | PDF ↗ |
| K042728 | CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM | Novus Monitoring, Ltd. | 2004-10-22 | Traditional | PDF ↗ |
| K040235 | LICOX PMO BRAIN MONITORING SYSTEM | Integra LifeSciences Corporation | 2004-04-20 | Traditional | PDF ↗ |
| K032337 | HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 | Hemedex Incorporated | 2003-10-21 | Traditional | PDF ↗ |
| K031086 | CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 | Integra Neurosciences | 2003-05-14 | Special | PDF ↗ |
| K022638 | NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT | Neurorecovery, Inc. | 2002-10-31 | Traditional | PDF ↗ |
| K020285 | CMA CEREBRAL TISSUE MONITORING SYSTEM | Cma Microdialysis AB | 2002-10-23 | Traditional | PDF ↗ |
| K013705 | ACT III VENTRICULAR CATHETER | Innerspace, Inc. | 2002-09-09 | Traditional | PDF ↗ |
| K022553 | CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L | Integra Neurosciences | 2002-08-20 | Special | PDF ↗ |
| K020780 | TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP | Medex, Inc. | 2002-05-20 | Abbreviated | PDF ↗ |
| K020558 | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE | Integra Neurosciences | 2002-03-21 | Special | PDF ↗ |
| K013930 | NEUROSENSOR | Novus Monitoring, Ltd. | 2002-02-20 | Traditional | PDF ↗ |
| K003759 | AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR | Aesculap, Inc. | 2001-06-28 | Traditional | PDF ↗ |
| K010422 | ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER | Innerspace, Inc. | 2001-06-28 | Traditional | PDF ↗ |
| K003905 | ACTI-ICP MONITORING SYSTEM | Innerspace, Inc. | 2001-06-15 | Traditional | PDF ↗ |
| K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE | Integra Neurosciences | 2000-11-24 | Traditional | PDF ↗ |
| K002392 | VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V | Integra Neurocare, LLC | 2000-11-02 | Traditional | PDF ↗ |
| K992591 | CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS | Codman & Shurtleff, Inc. | 1999-10-15 | Traditional | PDF ↗ |
| K980380 | NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS | Diametrics Medical, Ltd. | 1999-07-14 | Traditional | PDF ↗ |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | Johnson & Johnson Professionals, Inc. | 1999-07-09 | Traditional | PDF ↗ |
| K983799 | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL | Medtronic PS Medical | 1999-01-26 | Traditional | PDF ↗ |
| K982702 | VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD | Camino Neurocare, Inc. | 1998-09-10 | Traditional | PDF ↗ |
| K981846 | PARENCHYMAL BOLT PRESSURE MONITORING KIT | Camino Neurocare, Inc. | 1998-08-18 | Traditional | PDF ↗ |
| K974088 | CODMAN INTRACRANIAL BOLT | Johnson & Johnson Professionals, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K962928 | COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) | Camino Neurocare, Inc. | 1996-12-20 | Traditional | PDF ↗ |
| K945585 | COMAN(R) CU-11 MODEL NUMBER 82-6634 | Johnson & Johnson Professionals, Inc. | 1995-10-26 | Traditional | PDF ↗ |
| K931609 | CHARTR ENG SYSTEM | Ics Medical Corp. | 1995-09-26 | Traditional | PDF ↗ |
| K940648 | CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER | Cordis Corp. | 1995-03-01 | Traditional | PDF ↗ |
| K943987 | OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE | Innerspace Medical, Inc. | 1994-12-07 | Traditional | PDF ↗ |
| K914479 | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER | Codman & Shurtleff, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K930221 | CAMINO VENTRICULAR TRANSDUCER ACCESSORY | Camino Laboratories, Inc. | 1993-04-15 | Traditional | PDF ↗ |
| K912139 | MODEL 704 | Ivy Biomedical Systems, Inc. | 1992-03-25 | Traditional | PDF ↗ |
| K914735 | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM | Camino Laboratories, Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K884823 | TRANSPAC(R) II, DISPOSABLE TRANSDUCER | Abbott Laboratories | 1990-07-03 | Traditional | PDF ↗ |
| K896834 | MODEL BT-1 FOT BOLT INSTALLATION KIT | Pearl Instruments Corp. | 1990-02-23 | Traditional | PDF ↗ |
| K893395 | MINI-MONITOR J7000 ICP | Ladd Research Industries, Inc. | 1989-11-22 | Traditional | PDF ↗ |
| K890468 | MODEL FT-100 INTRACRANIAL PRESSURE MONITOR | Pearl Instruments Corp. | 1989-04-26 | Traditional | PDF ↗ |
| K883881 | MODIFIED MODEL 2001 FIBER OPTICS CATHETER | Metatech Corp. | 1988-10-27 | Traditional | PDF ↗ |
| K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT | Metatech Corp. | 1988-09-22 | Traditional | PDF ↗ |
| K882552 | METATECH ROBINSON BOLT ACCESSORY | Metatech Corp. | 1988-09-08 | Traditional | PDF ↗ |
| K883115 | PMT SUBARACHNOID SCREW, MODEL NO.1350-2 | Pmt Corp. | 1988-08-29 | Traditional | PDF ↗ |
| K882286 | EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET | Metatech Corp. | 1988-07-18 | Traditional | PDF ↗ |
| K881183 | VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H | Camino Laboratories, Inc. | 1988-05-04 | Traditional | PDF ↗ |
| K880154 | METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM | Metatech Corp. | 1988-03-28 | Traditional | PDF ↗ |
| K862820 | LADD/STERITEK ICP MONITOR, CAT. NO. P3000 | Ladd Research Industries, Inc. | 1987-02-26 | Traditional | PDF ↗ |
| K863479 | MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL | Medical Measurements, Inc. | 1986-10-14 | Traditional | PDF ↗ |
| K853770 | CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT | Codman & Shurtleff, Inc. | 1986-10-06 | Traditional | PDF ↗ |
| K862012 | LADD MEDICAL S-2000 | Ladd Research Industries, Inc. | 1986-06-09 | Traditional | PDF ↗ |
| K853864 | INTRACRANIAL PRESSURE MONITORING KIT 070 | Camino Laboratories, Inc. | 1986-02-20 | Traditional | PDF ↗ |
| K854657 | INTRACRANIAL PRESSURE MONITORING CUP CATHETERS | Cordis Corp. | 1985-12-27 | Traditional | PDF ↗ |
| K844566 | ICP MONITOR MODEL 1000 | Advanced Ultrasonic Testing & Research Corp. | 1985-08-16 | Traditional | PDF ↗ |
| K840999 | PHILLY INFANT BOLT | Philadelphia Medical Specialties | 1984-04-04 | Traditional | PDF ↗ |
| K840003 | DISPOSABLE ICP KIT DIFF. SIZES | Codman & Shurtleff, Inc. | 1984-02-28 | Traditional | PDF ↗ |
| K822864 | INTRACRANIAL PRESSURE MONITORING DEVICE | Medex, Inc. | 1982-11-16 | Traditional | PDF ↗ |
| K822636 | CLASS II DEVICE FOR I.C.P. MONITORING | Philadelphia Medical Specialties | 1982-09-14 | Traditional | PDF ↗ |
| K813440 | PHILLY BOLT | Philadelphia Medical Specialties | 1981-12-18 | Traditional | PDF ↗ |
| K802149 | TM-5 INTRACRANIAL PRESSURE MONITOR | Nicolet Biomedical Instruments | 1980-11-12 | Traditional | PDF ↗ |
| K802137 | CHEEK EPIDURAL SCREW | Codman & Shurtleff, Inc. | 1980-10-31 | Traditional | PDF ↗ |
Product code GWM · Class II · Neurology. Data: openFDA.