510(k) Report

FDA applicant

Nds Surgical Imaging

San Jose, CA10 decisions2008–20220 recalls

FDA records 10 decisions for Nds Surgical Imaging (San Jose, CA) from 2008 to 2022: 10 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 26 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nds Surgical Imaging, LLC”.

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 Nds Surgical Imaging’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 12010: 12012: 12013: 12014: 22015: 12016: 12017: 12022: 1
2008high 2 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Nds Surgical Imaging by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery6decisions
  • LLZSystem, Image Processing, Radiological4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 26 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 6 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.

  • K151609ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2Nds Surgical Imaging, LLC · 20153cite it
  • K100195NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video Transfer System, Model WU-WX-WY (Where U=R…Nds Surgical Imaging · 20103cite it
  • K161228Radiance Ultra Series ZeroWire EmbeddedNds Surgical Imaging, LLC · 20162cite it

What has FDA decided for it lately?

  • K222890Radiance Ultra 32 4K Zerowire DuoNds Surgical Imaging, LLC · 2022
  • K170598ZeroWire MobileNds Surgical Imaging, LLC · 2017
  • K161228Radiance Ultra Series ZeroWire EmbeddedNds Surgical Imaging, LLC · 2016
  • K151609ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2Nds Surgical Imaging, LLC · 2015
  • K133609The Dome S6CNds Surgical Imaging · 2014
  • K132770DOME S10Nds Surgical Imaging · 2014
  • K131115Zerowire Duo Wireless HD Video Transfer System, or Zero WireNds Surgical Imaging · 2013
  • K120709The Dome GX4MP Color NonitorNds Surgical Imaging · 2012

All 6 as Nds Surgical Imaging →All 4 as Nds Surgical Imaging, LLC →