Integra NeuroSciences
Anasco, PR, US
INTEGRA NEUROSCIENCES appears in FDA device records in Anasco, PR. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Integra NeuroSciences carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Integra Neurosciences PR, Inc.recall
510(k) clearance history
FDA records hold 9 510(k) clearances for Integra NeuroSciences between 2000 and 2008. The busiest year on record is 2002, with 4. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2002 | 4 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082250 | AURAGEN CORTICAL SURFACE ELECTRODES | GYC | Substantially Equivalent | |
| K050720 | NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 | GWM | Substantially Equivalent | |
| K042277 | SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM | LFL | Substantially Equivalent | |
| K031086 | CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 | GWM | Substantially Equivalent | |
| K021989 | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 | LFL | Substantially Equivalent | |
| K022554 | MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM | JXG | Substantially Equivalent | |
| K022553 | CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L | GWM | Substantially Equivalent | |
| K020558 | LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE | GWM | Substantially Equivalent | |
| K002765 | LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE | GWM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2648988 | 3000204775 | INTEGRA NEUROSCIENCES | ROAD 402 NORTH, KM 1.2, ANASCO, PR 00610 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LMFAgent, Absorbable Hemostatic, Collagen Based
- LYCBone Grafting Material, Synthetic
- HCDCannula, Ventricular
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- JXICuff, Nerve
- GWMDevice, Monitoring, Intracranial Pressure
- GXQDura Substitute
- GYCElectrode, Cortical
- GYKInstrument, Shunt System Implantation
- LFLInstrument, Ultrasonic Surgical
- LPGMaterial, Dressing, Surgical, Polylactic Acid
- LBKNeurosurgical Ultrasonic Instruments
- GADRetractor
- SELSecurement Wound Dressing For Reduction Of Infection
- JXGShunt, Central Nervous System And Components
- FTYTape, Measuring, Rulers And Calipers
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1051-2012 | "***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD .047", Large OD .058"***Plainsboro, NJ***" Step down connector to be secure with ligature | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. | Terminated | ||
| Z-1050-2012 | "***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g, 6"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. | Terminated | ||
| Z-1049-2012 | "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***" Collars for lumbar peritoneal shunt | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. | Terminated | ||
| Z-1048-2012 | "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g, 3.5"***Plainsboro, NJ***" Needle for lumbar peritoneal shunt | The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility. | Terminated | ||
| Z-1047-201 | "***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. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Integra NeuroSciences edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain