FDA product code · Gastroenterology and urology

Forceps, Biopsy, Non-Electric, Reprocessed

Name: FDA decisions, review times, recalls and adverse event reports for product code NON
Creator: 510(k) Report

NONClass I21 CFR 876.1075510(k) required3 decisions since 20051 recall

3 FDA decisions since 2005. 1 recall names this code; it is not Class I.

same as procode FCL except this product is for the reprocessed device. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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 NON 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 · NON

FDA has decided no NON device since 2007.

Median 510(k) review, days · NON

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

Recalls per year · NON

1in 2008

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NON

1in 2025

2007high 27 (2016) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	1	0
2009	—	0	0
2010	—	0	2
2011	—	0	0
2012	—	0	9
2013	—	0	0
2014	—	0	0
2015	—	0	1
2016	—	0	27
2017	—	0	6
2018	—	0	1
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	1
2026	—	0	—

FIG. 1 — NON by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NON? 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 876.1075.

FCK Instrument, Biopsy, Suction FFF Cover, Biopsy Forceps KNW Instrument, Biopsy NLS Instrument, Biopsy, Reprocessed FCF Instrument, Biopsy, Mechanical, Gastrointestinal FCI Punch, Biopsy FCG Biopsy Needle NMX Needle And Needle Set, Gastro-Urology…POZ Biopsy Needle Kit FCL Forceps, Biopsy, Non-Electric QHC Instrument, Biopsy, Core, Soft Tissue, Female…PRV Gastro-Urology Biopsy Kit

Forceps, Biopsy, Non-Electric, Reprocessed

Which NON devices have the deepest lineage?

What has FDA decided in NON lately?

What has been recalled in NON lately?

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