Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2085947

FEI Number

3000204191

Entity Name

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

City/State/Country

CANOGA PARK, CA, US

Establishment Address

22134 SHERMAN WAY, CANOGA PARK, CA 91303, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. (Owner Number: 9027397)

Owner / Operator Contact Address

22134 SHERMAN WAY, --, Canoga Park, CA 91303, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AED Sinus Punch AED Modular Bipolar Instruments AED Bipolar Cables FLEXLAP® Bipolar Articulating Instruments AED Bipolar Instruments Precise Bipolar L-Hook AED Bipolar Lap Forceps AED Storz (style) Bipolar Cables AED Bipolar Laparoscopic Forceps AED Bipolar Cauteries AED Otoscope AED Otoscope Inflation Bulb AED 801.3400 Flex Rhinoscope AED 801.2801 Flex Rhinoscope GREEN M/L HEMO-LOCK FORCEP GOLD XTRA LARGE HEMO-LOCK FORCEP HEMO-LOCK CLIP APPLIER X-LARGE CLIPS, 10MM X 33CM HEMO-LOCK CLIP APPLIER MEDIUM/LARGE CLIPS, 5MM X 25CM HEMO-LOCK CLIP APPLIER LARGE CLIPS, 10MM X 25CM HEMO-LOCK CLIP APPLIER MEDIUM/LARGE CLIPS, 5MM X 45CM HEMO-LOCK REMOVER MEDIUM/LARGE AND LARGE CLIPS, 5MM X 33CM PURPLE LARGE HEMO-LOCK FORCEP HEMO-LOCK CLIP APPLIER X-LARGE CLIPS, 10MM X 45CM AED H1616-R10 10MM X 33CM HEMO-LOCK REMOVER HEMO-LOCK CLIP APPLIER LARGE CLIPS, 10MM X 45CM CLIP APPLIER FOR LT400, SINGLE ACTION, LARGE CLIPS, 10MM X 45CM HEMO-LOCK CLIP APPLIER LARGE CLIPS, 10MM X 33CM HEMO-LOCK CLIP APPLIER X-LARGE CLIPS, 10MM X 25CM HEMO-LOCK CLIP APPLIER MEDIUM/LARGE CLIPS, 5MM X 33CM AED Storz (style) Albarran Deflector AED Mauermayer Stone Punches AED Cysto Bridges AED HD Ureteroscopes AED Olympus Mount Cystoscope AED 3 Prong Grasper Nephro Forceps AED Albarran Deflectors AED Ureteroscopes AED Laser Cystoscopes AED ACMI (style) Laser Cystoscopes AED Wolf Mount Cystoscope AED Endoscopes AED Storz (style) Stopcock AED Storz Mount Cystoscope AED Stent Forceps AED TRU VU Continous Flow Laser Cystoscope AED Cysto Sheaths AED Cysto Ureterscope Sheaths AED Double Channel Albarran Deflector AED Storz (style) Cysto Bridges AED Albarran Catheter Deflector AED Cysto Ureteroscopes AED Visual Obturators AED Optical Forceps AED Flexible Forceps AED Cystoscopes AED Micro HD Ureteroscopes AED Verres Needles AED TRU VU Nephroscopes AED Stone Forceps TRU VU Continous Flow Cystoscopes AED Office Cystoscope Set AED TRU VU Ureterscopes AED Gold Cystoscopes AED Storz (style) Cysto Sheaths AED Stryker Mount Cystoscope AED Urethro-Sheath, Optical Urethrotome AED Outer Sheath, Optical Urethrotome AED Telescope Bridge, Optical Urethrotome AED Serrated Blade, Cold Knife AED Urethrotomes AED Half Moon Blade, Cold Knife AED Straight Blade, Cold Knife AED Supplemental Sheath, Optical Urethrotome AED Urethrotome Set AED Otis Urethrotome AED Outer Sheath Optical Urethrotome AED Sinus Sickle Knife Precise Lap Bulldog Clamp Lap Endoscopic Clip Applier AED Sinus Forceps AED Biopsy Cup Forcep AED Sinus Clamp Forcep AED Sinus Grasper Forcep AED Antrum Punch Precise Lap Bulldog Clamp Lap Endoscopic Clip Applier AED-SLT SLT-PUMP SLT-ART SLT-DYO SLT-STK SLT-KIT SLT-C-L SLT-MR AED-SLT STRYKER SMALL JOINT-STOP AED-SLT MEDTRONIC-STOP AED Sinus Irrigation AED Sinus Scissors AED Solar 3000 Surgical Wireless LED Head Light AED Solar 1000 Surgical LED Head Light AED OL-160 150 Watt Halogen w/ Cable Turret LAP PRO KITE RETRACTOR, CURVED, 5MM X 45CM LAP PRO FAN RETRACTOR, 5 BLADE, 10MM FLEXLAP® RETRACTOR TRIANGLE SHAPE LAP PRO KITE RETRACTOR, STRAIGHT, 5MM X 33CM LAP PRO KITE RETRACTOR, STRAIGHT, 5MM X 45CM FLEXLAP® RETRACTOR TRIANGLE SHAPE, TIP ARTICULATES 40 DEGREES FLEXLAP® GOLD FINGER RETRACTOR, ARTICULATES 90 DEGREES LAP PRO FAN RETRACTOR, 3 BLADE FAN, 5MM LAP PRO KITE RETRACTOR, CURVED, 5MM X 33CM LAP PRO S-RETRACTOR AED 578825 LOWSLEY RETRACTOR AED 578830 LOWSLEY RETRACTOR AED Ellik Adapter AED Ellik Syringe AED Ellik Evacuator AED Solar 2000 Portable LED Light Source AED Solar 4000 50-WATT LED Light Source AED 50-WATT LED Light Source AED Solar 5000 Portable LED Light Source AED Solar 4500 50-Watt LED Light Source AED Solar 2010 Portable LED Light Source AED Inflow Cannula AED Flexible Forceps AED Arthroscopy Sheaths AED Wolf Mount Arthroscopy Sheaths AED Arthroscopy Switching Sticks AED Storz Mount Arthroscopy Sheaths AED Arthro-Pro AED Arthroscopy Forceps AED Arthro Suture Forcep AED Arthro Forceps AED Arthro Instruments AED Stryker Mount Arthroscopy Sheaths AED Sinus Cannula AED Sinus Trocar AED Arthro Forceps AED Arthroscopy Forceps AED Arthroscopy Sheaths AED Stryker Mount Arthroscope AED Storz Mount Arthroscope AED Olympus Mount Arthroscope AED Wolf Mount Arthroscope AED Arthroscope AED Endoscope AED LED Stroboscope AED Myoma Screw Micro Precise Compact Needle Holders FLEXLAP® Retractors AED Clip Appliers AED Laparoscopic Band Retractors AED Trocar/Cannula Leaf Valve Mini Precise Suction Probe Eco Fit Needle Holders FLEXLAP® Gold Finger Retractors Titanium Pistol Handle Needle Holders AED Lap Retractors Precise Modular Needle Holders Hemo-Lock Clip Appliers Precise Lap Articulating Bulldog Clamp Forceps AED Trocars/Cannulas Caps Euro Axial Needle Holders AED Closed End Knot Pusher Clipper Laparoscopic Clip Appliers AED Lap Forcep Cables AED Trocars/Cannulas Valves Precise Rotator Caps Euro Ring Needle Holders AED Curved Slotted Knot Pusher AED Slotted Knot Pusher Mini Precise Kite Retractor AED Micro Axial Needle Holders AED Palpation Probe Mini Precise Compact Needle Holders AED Long Pencil Nose Knot Pusher AED Suture Passer Cones Precise Bulldog 3-Prong Grasper Precise Needle Holders Lap Pro Flow Suction Irrigators AED Laparoscopic Bariatric Retractor Mini Precise Trocar/Cannula AED-Romeo Needle Holder AED Trocar/Cannulas FLEXLAP® Retractor Triangle Shape AED Knot Pusher Micro Precise Suction Probe FLEXLAP® Retractor Large D Shape AED Fascia Close Forceps Surgeon's Choice Needle Holders Lap Pro Retractors Micro Precise Trocar/Cannula AED Meeker Forceps Titanium Axial Handle Needle Holders Micro Precise Palpation Probe Precise Lap Bulldog Clamp Forceps Mini Precise Palpation probe AED Cannula AED Hysteroscope and accessories AED Hysteroscopy Forceps AED Hysteroscope AED Operative Hysteroscope AED Hystero Resectoscope AED Hysteroscopic Sheaths AED Mini Hysteroscope AED Hystero Forceps Precise Curved Morcellation Knife AED Flexible Forceps AED Hystero Sheaths Precise Curved Morcellation Knives AED Hystero Resectoscope Working Elements AED Hystero Resectoscope Sheaths AED Hystero Insulated Tenaculum Forcep AED Cohen (style) Uterine Cannula AED Hystero Resectoscope Cauteries AED Hystero Insulated Speculum with Suction Port AED Hystero Lateral Wall Retractor AED Hystero Resectoscopes AED Hystero Resectoscope Hi-Frequency Cables AED Hystero Sheath Double Seal Lure Cap AED Hystero Scissor, Single Action AED Hystero Pointed Scissor, Single Action AED Hystero Grasper, Double Action AED Hystero Cup Biopsy, Double Action AED Hystero Hook Scissor, Single Action AED Hystero Tenaculum, Double Action AED Instrument Bridge AED CLOSED END KNOT PUSHER, 5MM, 45CM AED 10MM SUTURE PASSER CONE AED SLOTTED KNOT PUSHER, 5MM, 45CM AED CURVED SLOTTED KNOT PUSHER, 55, 45CM AED SLOTTED KNOT PUSHER, 5MM, 33CM ARTHRO-PRO TISSUE GRASPER AED 5FR PENCIL TIP KNOT PUSHER AED CLOSED END KNOT PUSHER, 5MM, 33CM AED CURVED SLOTTED KNOT PUSHER, 55, 33CM AED FASCIA CLOSE FORCEP 2.4MM AED 5FR CLARKE KNOT PUSHER AED 12MM SUTURE PASSER CONE AED FASCIA CLOSE FORCEP 3MM ARTHRO-PRO SUTURE MANIPULATOR GRASPER AED Sinuscope AED Rigid Bronchoscope AED Sinus Speculum AED Pin-Wire Cutter AED Wire Cutter AED TC GOLD Plate Cutter AED Cable Cutter AED TC GOLD Pin Cutter AED TC GOLD Pin End Cutter AED Extractor Plier Forcep AED TC Gold Straight Wire Cutter AED TC Gold Side Pin Cutter AED TC Gold Grooved Pin Cutter AED TC Gold Angled Wire Cutter AED Pin Cutter AED Pin-Wire Side Cutter AED Resectoscope Sheaths AED Laser Resectoscope AED Resectoscopes consisting of and visual obturators and endoscopes. AED Albarran Deflectors AED Bipolar Cutting Loops AED Monopolar Cutting Loops AED Resectoscope Electrodes AED Resectoscopes consisting of coagulation and cutting electrodes, standard timberlake (deflecting) and AED Working Elements AED Resectoscopes consisting of working elements, standard and continuous irrigation, resectoscope sheaths and AED Laser Working Elements AED Bipolar Working Elements AED Laser Resectoscope Working Elements AED Resectoscope Sets AED Hystero Resectoscope Cauteries AED Hystero Resectoscope Hi-Frequency Cables AED Hystero Resectoscope Sheaths AED Storz (style) Resectoscope Sheaths AED Hystero Resectoscope Working Elements AED Hystero Resectoscopes AED Storz (style) Hi-Frequency Cables AED Laser Resectoscopes AED Storz (style) Electrodes AED HF-Bipolar Resectoscope Cables AED TRU VU Laser Resectoscope Systems Surgeon's Choice Needle Holders AED-Romeo Needle Holder Euro Axial Needle Holders Titanium Pistol Handle Needle Holders Eco Fit Needle Holders Euro Ring Needle Holders Titanium Axial Handle Needle Holders AED Micro Axial Needle Holders Mini Precise Compact Needle Holders Precise Modular Needle Holders Micro Precise Compact Needle Holders Precise Needle Holders

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-08-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-12-10
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2016-08-16
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2016-08-16
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2019-03-15
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2010-12-10
EZO	Urethrotome	Gastroenterology, Urology	Class 2	876.4770	2015-11-06
KAS	Knife, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-08-16
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2019-01-31
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-08-16
KAW	Punch, Antrum	Ear, Nose, Throat	Class 1	874.4420	2016-08-16
FFR	Device, Locking, For Intestinal Clamp	Gastroenterology, Urology	Class 1	876.4730	2019-01-31
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2020-07-24
KAR	Irrigator, Sinus	Ear, Nose, Throat	Class 1	874.4420	2016-08-16
KBD	Scissors, Nasal	Ear, Nose, Throat	Class 1	874.4420	2016-08-16
FSR	Light, Headband, Surgical	Ophthalmic	Class 2	886.4335	2015-11-06
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2018-10-18
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2019-03-15
KQT	Evacuator, Gastro-Urology	Gastroenterology, Urology	Class 2	876.4370	2015-11-06
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2016-08-16
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2015-11-06
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2016-08-16
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-08-16
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2010-12-10
EQL	Laryngostroboscope	Ear, Nose, Throat	Class 1	874.4750	2015-11-06
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2015-11-06
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2015-11-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-07-09
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2019-03-15
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2017-08-23
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2016-08-16
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2016-08-16
FDC	Resectoscope, Working Element	Gastroenterology, Urology	Class 2	876.1500	2012-08-10
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2012-08-10
FJL	Resectoscope	Gastroenterology, Urology	Class 2	876.1500	2012-08-10
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2015-11-06

Official Correspondent

JOHN DAWOODJEE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

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K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
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K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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9680718	RZ MEDIZINTECHNIK GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2085947. Last updated year: 2026. Please use registration number 2085947 when referencing this establishment in official correspondence.