510(k) Report

FDA product code · General and plastic surgery

Device, Endoscopic Suturing

MFJClass II21 CFR 876.1500510(k) required1 decision since 19910 recalls

1 FDA decision since 1991. No recall names this code.

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 MFJ 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 · MFJ

FDA has decided no MFJ device since 2007.

Median 510(k) review, days · MFJ

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

Recalls per year · MFJ

No recall names MFJ since 2007.

Adverse event reports per year · MFJ

1in 2023

2007: 512008: 1122009: 1152010: 402011: 222012: 112013: 42014: 52015: 112016: 62017: 42018: 12023: 1
2007high 115 (2009) · low 0 (2019)2025

MAUDE reports naming product code MFJ, 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—051
20080—0112
20090—0115
20100—040
20110—022
20120—011
20130—04
20140—05
20150—011
20160—06
20170—04
20180—01
20190—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—
FIG. 1 — MFJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MFJ? 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.