510(k) Report

FDA applicant

National Advanced Endoscopy Devices, Inc.

Canoga Park, CA8 decisions1999–20170 recalls

FDA records 8 decisions for National Advanced Endoscopy Devices, Inc. (Canoga Park, CA) from 1999 to 2017: 8 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 7 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided National Advanced Endoscopy Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 22010: 12015: 12017: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — National Advanced Endoscopy Devices, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like National Advanced Endoscopy Devices…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • GCJLaparoscope, General & Plastic Surgery1decision
  • FAJCystoscope And Accessories, Flexible/Rigid1decision
  • HIHHysteroscope (And Accessories)1decision
  • EOBNasopharyngoscope (Flexible Or Rigid)1decision
  • HRXArthroscope1decision

Also: FJL (1).

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K993688Aed LaparoscopeNational Advanced Endoscopy Devices, Inc. · 19991cites it
  • K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 20081cites it

What has FDA decided for it lately?

  • K170285AED SinuscopeNational Advanced Endoscopy Devices, Inc. · 2017
  • K141515Aed Hysteroscope and AccessoriesNational Advanced Endoscopy Devices, Inc. · 2015
  • K102663Aed ResectoscopeNational Advanced Endoscopy Devices, Inc. · 2010
  • K081553Aed Bipolar Forceps, Model 13-1646National Advanced Endoscopy Devices, Inc. · 2008
  • K081503Aed Monopolar Lap AccessoriesNational Advanced Endoscopy Devices, Inc. · 2008
  • K993689Aed CystoscopeNational Advanced Endoscopy Devices, Inc. · 1999
  • K993688Aed LaparoscopeNational Advanced Endoscopy Devices, Inc. · 1999
  • K991656Aed ArthroscopeNational Advanced Endoscopy Devices, Inc. · 1999

All 8 as National Advanced Endoscopy Devices, Inc. →