510(k) Report

FDA applicant

Ultroid, LLC

Carson City, NV2 decisions2003–20034 recalls

FDA records 2 decisions for Ultroid, LLC (Carson City, NV) in 2003: 2 510(k) clearances. All are in product code KNS (Unit, Electrosurgical, Endoscopic (With Or…). 4 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 Ultroid, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ultroid, LLC since 2007.

Recalls per year

4in 2016

2016: 4
2007high 4 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ultroid, LLC’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?

  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)2decisions

What has FDA decided for it lately?

  • K030315Modification to Ultroid Hemorrhoid Management SystemUltroid, LLC · 20034 recalls
  • K023706Ultroid Hemorrhoid Management SystemUltroid, LLC · 20034 recalls

All 2 as Ultroid, LLC →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K023706Ultroid Sterile Disposable Probes sold individuallyOct 19, 2016Class II
  • K023706Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the…Oct 19, 2016Class II
  • K023706Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable…Oct 19, 2016Class II
  • K023706Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.Oct 19, 2016Class II