510(k) Report

FDA product code · Obstetrics and gynecology

Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar

PGTClass II21 CFR 884.1710510(k) required3 decisions since 20140 recalls

3 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 58 days (half between 58 and 58). No recall names this code. The most-cited predicate is DEN130040, named by 1 later device.

to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy. It is also intended for cutting and coagulation of uterine tissue.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of PGT at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PGT

1in 2024

2014: 22024: 1
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGT

Too few PGT 510(k)s in any year since 2007 to give a median.

Recalls per year · PGT

No recall names PGT since 2007.

Adverse event reports per year · PGT

1in 2025

2015: 72016: 192017: 392018: 172019: 132020: 72021: 52022: 12023: 52024: 22025: 1
2007high 39 (2017) · low 0 (2007)2025

MAUDE reports naming product code PGT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20142—00
20150—07
20160—019
20170—039
20180—017
20190—013
20200—07
20210—05
20220—01
20230—05
20241—02
20250—01
20260—0—
FIG. 1 — PGT by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PGT? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PGT devices cite most?

Devices in this code that later submissions most often claim equivalence to.

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

Which PGT devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc. · 20248generations
  • K141848Iogyn SystemIogyn, Inc. · 20141generation

What has FDA decided in PGT lately?

  • K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc. · 2024
  • K141848Iogyn SystemIogyn, Inc. · 2014
  • DEN130040Iogyn SystemIogyn, Inc. · 2014

All 3 PGT decisions →