510(k) Report

FDA applicant

Corinth Medtech, Inc.

Cupertino, CA7 decisions2017–20230 recalls

FDA records 7 decisions for Corinth Medtech, Inc. (Cupertino, CA) from 2017 to 2023: 7 510(k) clearances. Most are in product codes FJL (Resectoscope) and HIH (Hysteroscope (And Accessories)). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 7 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 Corinth Medtech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12018: 12019: 42023: 1
2017high 4 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Corinth Medtech, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Corinth Medtech, Inc.’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?

  • FJLResectoscope4decisions
  • HIHHysteroscope (And Accessories)3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 91 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 15 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 7 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.

  • K162979Veloxion SystemCorinth Medtech, Inc. · 20173cite it
  • K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 20192cite it
  • K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 20191cites it
  • K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set…Corinth Medtech, Inc. · 20181cites it
  • K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 20191cites it

What has FDA decided for it lately?

  • K230205Veloxion SystemCorinth Medtech, Inc. · 2023
  • K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K191335Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K190113Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit…Corinth Medtech, Inc. · 2019
  • K180752Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set…Corinth Medtech, Inc. · 2018
  • K162979Veloxion SystemCorinth Medtech, Inc. · 2017

All 7 as Corinth Medtech, Inc. →