510(k) Report

FDA applicant

New Wave Surgical Corporation

Great Neck, NY1 decision2006–20062 recalls

FDA records 1 decision for New Wave Surgical Corporation (Great Neck, NY) in 2006: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 10 predicates, 0 of them its own earlier devices. 2 recalls are 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 New Wave Surgical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for New Wave Surgical Corporation since 2007.

Recalls per year

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — New Wave Surgical Corporation 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?

  • GCJLaparoscope, General & Plastic Surgery1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp)New Wave Surgical Corporation · 20065cite it

What has FDA decided for it lately?

  • K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp)New Wave Surgical Corporation · 20062 recalls

The one decision as New Wave Surgical Corporation →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K062779Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to…Oct 4, 2016Class II
  • K062779Best Practices kits containing certain production lots of Clearify Visualization System…Oct 4, 2016Class II