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Data / Medical devices / United States / National Advanced Endoscopy Devices, Inc.

National Advanced Endoscopy Devices, Inc.: FDA-registered device maker in Canoga Park, CA, United States, 10 510(k) clearances

National Advanced Endoscopy Devices, Inc. is registered with the FDA (registration 2085947) in Canoga Park, CA, United States. It lists 46 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 1, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
2085947
FEI number
3000204191
Address
22134 Sherman Way, Canoga Park, CA, United States, 91303
Owner or operator
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. (9027397)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 10, 2010
Registered through
2026
Brand names listed
AED 10MM SUTURE PASSER CONE, AED 12MM SUTURE PASSER CONE, AED 3 Prong Grasper Nephro Forceps, AED 50-WATT LED Light Source, AED 578825 LOWSLEY RETRACTOR, AED 578830 LOWSLEY RETRACTOR, AED 5FR CLARKE KNOT PUSHER, AED 5FR PENCIL TIP KNOT PUSHER and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM1Manufactureraccessdata.fda.gov
Applier, Surgical, ClipGDO1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ArthroscopeHRX2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Bag, IntestineKGY1Repackager or relabeleraccessdata.fda.gov
Camera, Television, Endoscopic, Without AudioFWF1Repackager or relabeler, Specification developeraccessdata.fda.gov
Camera, Television, Microsurgical, Without AudioFWD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cannula, SinusKAM1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ClampHXD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cutter, WireHXZ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Locking, For Intestinal ClampFFR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrode, Electrosurgical, Active, UrologicalFAS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Contract manufacturer, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Elevator, EntKAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Evacuator, Gastro-UrologyKQT2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, EntKAE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufactureraccessdata.fda.gov
Gouge, Nasal, EntKAQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Irrigator, SinusKAR1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Knife, NasalKAS1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laparoscopic Accessories, GynecologicNWV1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Laryngoscope, RigidCCW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
LaryngostroboscopeEQL1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Led Light SourceNTN2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light Source, Fiberoptic, RoutineFCW2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Light, Headband, SurgicalFSR2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Motor, Surgical Instrument, Ac-PoweredGEY1Manufactureraccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Manufacturer, Repackager or relabeleraccessdata.fda.gov
OtoscopeERA1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Punch, AntrumKAW1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Punch, NasalKAY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
ResectoscopeFJL2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Resectoscope, Working ElementFDC2Manufacturer, Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Rongeur, ManualHAE2Repackager or relabeleraccessdata.fda.gov
Scissors, NasalKBD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Source, Carrier, Fiberoptic LightEQH1Repackager or relabeleraccessdata.fda.gov
Speculum, EntEPY1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Trocar, EntKTE1Manufacturer, Repackager or relabeleraccessdata.fda.gov
UrethrotomeEZO2Manufacturer, Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
August 1, 2017K170285AED SinuscopeEOBSubstantially EquivalentNational Advanced Endoscopy Devices, Inc.accessdata.fda.gov
January 7, 2015K141515AED HYSTEROSCOPE AND ACCESSORIESHIHSubstantially EquivalentNational Advanced Endoscopy Devices, Inc.accessdata.fda.gov
December 30, 2010K102663AED RESECTOSCOPEFJLSubstantially EquivalentNational Advanced Endoscopy Devices, Inc.accessdata.fda.gov
September 29, 2008K081553AED BIPOLAR FORCEPS, MODEL 13-1646GEISubstantially EquivalentNational Advanced Endoscopy Devices, Inc.accessdata.fda.gov
September 25, 2008K081503AED MONOPOLAR LAP ACCESSORIESGEISubstantially EquivalentNational Advanced Endoscopy Devices, Inc.accessdata.fda.gov
April 2, 2008K080622ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105EOBSubstantially EquivalentOptim, Inc.accessdata.fda.gov
February 7, 2003K023868DAN KERRISON RONGEURS, MODELS K1 + BILLY 1HAESubstantially EquivalentDannoritzer Medical Instrumentsaccessdata.fda.gov
December 15, 1999K993689AED CYSTOSCOPEFAJSubstantially EquivalentNational Advanced Endoscopy Devices, Inc.accessdata.fda.gov
December 6, 1999K993688AED LAPAROSCOPEGCJSubstantially EquivalentNational Advanced Endoscopy Devices, Inc.accessdata.fda.gov
December 2, 1999K991656AED ARTHROSCOPEHRXSubstantially EquivalentNational Advanced Endoscopy Devices, Inc.accessdata.fda.gov

Compare with other makers

Updated August 1, 2017. 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.