510(k) Report

FDA product code · General and plastic surgery

Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

QGYClass II21 CFR 876.1500510(k) required1 decision since 20190 recalls

1 FDA decision since 2019. No recall names this code. The most-cited predicate is K190367, named by 1 later device.

Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.

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, general and plastic surgery panel

Twenty years of QGY 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 · QGY

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QGY

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

Recalls per year · QGY

No recall names QGY since 2007.

Adverse event reports per year · QGY

No MAUDE report names QGY since 2007.

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
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — QGY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QGY? 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

Related product codes

Other codes under 21 CFR 876.1500.