510(k) Report

FDA applicant

Endooptiks, Inc.

Little Silver, NJ5 decisions1992–20090 recalls

FDA records 5 decisions for Endooptiks, Inc. (Little Silver, NJ) from 1992 to 2009: 5 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and EYB (Catheter, Ureteral, Gastro-Urology). Its devices cite 2 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, general and plastic surgery panel, where it files most

How often FDA has decided Endooptiks, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument3decisions
  • EYBCatheter, Ureteral, Gastro-Urology1decision
  • EOBNasopharyngoscope (Flexible Or Rigid)1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K042918Microprobe Laser and Endoscopy System, Model E2Endooptiks, Inc. · 20041cites it

What has FDA decided for it lately?

  • K083788Endo Optiks Urological Catheter for Endoscopy, Model SessrEndooptiks, Inc. · 2009
  • K042918Microprobe Laser and Endoscopy System, Model E2Endooptiks, Inc. · 2004
  • K003151Micropobe Series of Lasers and AccessoriesEndooptiks, Inc. · 2001
  • K945081Transtympanic EndoscopeEndooptiks, Inc. · 1995
  • K922917EndoprobesEndooptiks, Inc. · 1992

All 5 as Endooptiks, Inc. →