Data / Medical devices / United States / Integra Neurosciences
Integra Neurosciences: FDA-registered device maker in Anasco, PR, United States, 40 510(k) clearances and 2 PMA approvals
Integra Neurosciences is registered with the FDA (registration 2648988) in Anasco, PR, United States. It lists 13 device types. The FDA files 40 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 11, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2648988
- FEI number
- 3000204775
- Address
- Road 402 North, KM 1.2, Anasco, PR, United States, 00610
- Owner or operator
- Integra LifeSciences Corporation (9004007)
- Roles
- Manufacturer
- First device listed
- April 24, 1981
- Registered through
- 2026
- Brand names listed
- Accudrain External CSF Drainage Sys, Alleghany CSF External Drainage Sys, Arkis Galea Elevator, BioMend Absorbable Collagen Membrane, Biomend Extend Absorbable Collagen Membrane, Biopatch, Braden Reservoir, CUSA Clarity 23 kHz Single-Sided Bone Tip and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Absorbable Hemostatic, Collagen Based | LMF | 3 | Manufacturer | accessdata.fda.gov |
| Bone Grafting Material, Synthetic | LYC | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Cuff, Nerve | JXI | 2 | Manufacturer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Shunt System Implantation | GYK | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Ultrasonic Surgical | LFL | U | Manufacturer | accessdata.fda.gov |
| Material, Dressing, Surgical, Polylactic Acid | LPG | 3 | Manufacturer | accessdata.fda.gov |
| Neurosurgical Ultrasonic Instruments | LBK | U | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Manufacturer | accessdata.fda.gov |
| Securement Wound Dressing For Reduction Of Infection | SEL | U | Manufacturer | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | Manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 11, 2023 | K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| August 22, 2022 | K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| July 15, 2022 | K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 11, 2019 | K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| April 1, 2019 | K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 7, 2018 | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| October 14, 2016 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| September 22, 2016 | K161992 | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| March 14, 2016 | K153041 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| November 6, 2014 | K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| December 7, 2007 | K072929 | LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| August 23, 2007 | K072207 | DURAGEN XS DURAL REGENERATION MATRIX | GXQ | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| September 27, 2006 | K062599 | MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| January 12, 2005 | K043427 | DURAGEN II DURAL REGENERATION MATRIX | GXQ | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| December 21, 2004 | K042825 | ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM | JXG | Substantially Equivalent | Integra LifeSciences Corporation | accessdata.fda.gov |
| July 16, 2004 | K041620 | NEURA WRAP NERVE PROTECTOR | JXI | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| September 30, 2003 | K032693 | DURAGEN PLUS DURAL GRAFT MATRIX | GXQ | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| February 26, 2003 | K030289 | HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N | JXG | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| August 23, 2002 | K022554 | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | JXG | Substantially Equivalent | Integra Neurosciences | accessdata.fda.gov |
| October 26, 2001 | K003229 | BIOPATCH ANTIMICROBIAL DRESSING | SEL | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| June 22, 2001 | K011168 | NEUROGEN NERVE GUIDE | JXI | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| July 26, 1999 | K992216 | BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE | LYC | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| July 6, 1999 | K982180 | DURAGEN DURAL GRAFT MATRIX | GXQ | Substantially Equivalent | Integra Lifesciences Corp. | accessdata.fda.gov |
| July 6, 1998 | K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | Valleylab, Inc. | accessdata.fda.gov |
| December 16, 1997 | K973525 | MAURICE WORLDWIDE SHUNT SYSTEM | JXG | Substantially Equivalent | Integra Neurocare, LLC | accessdata.fda.gov |
| November 3, 1997 | K972994 | EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS | JXG | Substantially Equivalent | Integra Neurocare, LLC | accessdata.fda.gov |
| July 31, 1997 | K971617 | ENDOSCOPIC VENTRICULAR CATHETER | JXG | Substantially Equivalent | Integra Neurocare, LLC | accessdata.fda.gov |
| May 19, 1997 | K970658 | LUMBAR DRAINAGE ACCESSORY KIT | JXG | Substantially Equivalent | Integra Neurocare, LLC | accessdata.fda.gov |
| August 22, 1995 | K924408 | COLLA-TEC ABSORBABLE COLLAGEN MEMBRANE | LYC | Substantially Equivalent | Colla-Tec, Inc. | accessdata.fda.gov |
| March 30, 1995 | K932769 | CAMINO VENTRICULAR DRAINAGE SYSTEM | JXG | Substantially Equivalent | Camino Laboratories, Inc. | accessdata.fda.gov |
| March 16, 1992 | K920156 | CLINICAL NEURO SYST MONITORR EXT CSF DRAIN/MONI SY | JXG | Substantially Equivalent | Clinical Neuro Systems, LLC | accessdata.fda.gov |
| October 31, 1989 | K895868 | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | GYK | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| August 7, 1989 | K894072 | THE PUDENZ IN LINE VALVE | JXG | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| December 29, 1986 | K864676 | HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM | JXG | Substantially Equivalent | American V. Mueller | accessdata.fda.gov |
| November 27, 1985 | K854049 | HEYER-SCHULTE SYRINGO PERITONEAL SHUNT | JXG | Substantially Equivalent | American V. Mueller | accessdata.fda.gov |
| February 18, 1982 | K820247 | EXTERNAL VENTRICULAR DRAINAGE SYS. | JXG | Substantially Equivalent | American Heyer Schulte | accessdata.fda.gov |
| June 26, 1981 | K811288 | SPETZLER LUMBAR-PERITONEAL SYSTEM | JXG | Substantially Equivalent | American Heyer Schulte | accessdata.fda.gov |
| December 18, 1980 | K802586 | AMERICAN HEYER-SCHULTE LOW PROFILE VALVE | JXG | Substantially Equivalent | American Heyer Schulte | accessdata.fda.gov |
| November 1, 1976 | K760785 | MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYPH | JXG | Substantially Equivalent | Heyer Schulte Corp. | accessdata.fda.gov |
| August 30, 1976 | K760502 | VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH. | JXG | Substantially Equivalent | Joe W. Utt | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 8, 1985 | P850010 | HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE | LMF | 113 | September 18, 2026 | accessdata.fda.gov |
| November 8, 1985 | P840062 | COLLACOTE(TM) | LPG | 94 | September 18, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 28, 2011 | 60599 | Not yet classified | Terminated | "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" Stainless steel stylet for ventricular catheter | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- All makers of Shunt, Central Nervous System And Components
- All makers of Bone Grafting Material, Synthetic
- All makers of Instrument, Ultrasonic Surgical
- All makers of Neurosurgical Ultrasonic Instruments
- All makers of Securement Wound Dressing For Reduction Of Infection
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.