510(k) Report

FDA product code · Anesthesiology

Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree

QECClass II21 CFR 876.4300510(k) required1 decision since 20180 recalls

1 FDA decision since 2018. No recall names this code.

An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree

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, anesthesiology panel

Twenty years of QEC 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 · QEC

1in 2018

2018: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QEC

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

Recalls per year · QEC

No recall names QEC since 2007.

Adverse event reports per year · QEC

No MAUDE report names QEC 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
20181—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — QEC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

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

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Related product codes

Other codes under 21 CFR 876.4300.