510(k) Report

FDA applicant

Iogyn, Inc.

Cupertino, CA3 decisions2013–20140 recalls

FDA records 3 decisions for Iogyn, Inc. (Cupertino, CA) from 2013 to 2014: 2 510(k) clearances and 1 De Novo grant. Most are in product codes PGT (Insufflator, Hysteroscopic, Fluid, Closed-Loop…) and HIH (Hysteroscope (And Accessories)). Its devices cite 3 predicates, 1 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

2in 2014

2013: 12014: 2
2013high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Iogyn, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Iogyn, 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?

  • PGTInsufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator…2decisions
  • HIHHysteroscope (And Accessories)1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • DEN130040Iogyn SystemIogyn, Inc. · 20141cites it
  • K141848Iogyn SystemIogyn, Inc. · 20141cites it

What has FDA decided for it lately?

  • K141848Iogyn SystemIogyn, Inc. · 2014
  • DEN130040Iogyn SystemIogyn, Inc. · 2014
  • K123330Iogyn EndoscopeIogyn, Inc. · 2013

All 3 as Iogyn, Inc. →