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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- 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
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 |
|---|---|---|---|---|---|---|
| August 1, 2017 | K170285 | AED Sinuscope | EOB | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| January 7, 2015 | K141515 | AED HYSTEROSCOPE AND ACCESSORIES | HIH | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| December 30, 2010 | K102663 | AED RESECTOSCOPE | FJL | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| September 29, 2008 | K081553 | AED BIPOLAR FORCEPS, MODEL 13-1646 | GEI | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| September 25, 2008 | K081503 | AED MONOPOLAR LAP ACCESSORIES | GEI | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| April 2, 2008 | K080622 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 | EOB | Substantially Equivalent | Optim, Inc. | accessdata.fda.gov |
| February 7, 2003 | K023868 | DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 | HAE | Substantially Equivalent | Dannoritzer Medical Instruments | accessdata.fda.gov |
| December 15, 1999 | K993689 | AED CYSTOSCOPE | FAJ | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| December 6, 1999 | K993688 | AED LAPAROSCOPE | GCJ | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
| December 2, 1999 | K991656 | AED ARTHROSCOPE | HRX | Substantially Equivalent | National Advanced Endoscopy Devices, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Urethrotome
- All makers of Forceps, Ent
- All makers of Speculum, Ent
- All makers of Camera, Television, Endoscopic, Without Audio
- All makers of Cannula, Sinus
- All makers of Light, Headband, Surgical
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.