510(k) Report

FDA product code · Gastroenterology and urology

Spatial Imaging For Display Of Endoscope Position

PGUClass II21 CFR 876.1500510(k) required1 decision since 20140 recalls

1 FDA decision since 2014. No recall names this code.

To detect and display the shape of an inserted endoscope.

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, gastroenterology and urology panel

Twenty years of PGU 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 · PGU

1in 2014

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

2026 to Oct 25, outlined.

Median 510(k) review, days · PGU

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

Recalls per year · PGU

No recall names PGU since 2007.

Adverse event reports per year · PGU

2in 2023

2017: 12022: 22023: 2
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code PGU, 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
20141—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—02
20230—02
20240—00
20250—00
20260—0—
FIG. 1 — PGU by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PGU? 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 PGU devices have the deepest lineage?

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

  • K134026Endoscope Position Marking Probe,Endoscope Position Detecting UnitOlympus Medical Systems Corp. · 20142generations

What has FDA decided in PGU lately?

  • K134026Endoscope Position Marking Probe,Endoscope Position Detecting UnitOlympus Medical Systems Corp. · 2014

The one PGU decision →

Related product codes

Other codes under 21 CFR 876.1500.

FAL Panendoscope (Urethroscope)FBO CystourethroscopeNWB Endoscope, Accessories, Narrow Band SpectrumKGD Scissors For CystoscopeFCZ Tube, Smoke Removal, EndoscopicFDW Esophagoscope, Rigid, Gastro-UrologyFGS Carrier, Sponge, EndoscopicGCM Endoscope, RigidGCN Endoscope, PrismFGA Kit, NephroscopeFAM Sigmoidoscope And Accessories, Flexible/RigidGDB Endoscope, Fiber Optic