FDA product code · General and plastic surgery

Suture Kit

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

OVNClass II21 CFR 878.48300 decisions1 recall

0 FDA decisions. 1 recall names this code; it is not Class I.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market…

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 OVN 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 · OVN

FDA has decided no OVN device since 2007.

Median 510(k) review, days · OVN

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

Recalls per year · OVN

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OVN

5in 2025

2007high 14 (2015) · low 0 (2007)2025

MAUDE reports naming product code OVN, 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	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	1
2015	—	0	14
2016	—	0	1
2017	—	0	1
2018	—	0	4
2019	—	0	4
2020	—	0	1
2021	—	0	1
2022	—	0	2
2023	—	0	0
2024	—	0	0
2025	—	0	5
2026	—	1	—

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

Planning a device in OVN? 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 878.4830.

GAL Suture, Absorbable, Natural GAK Suture, Absorbable GAN Suture, Absorbable, Synthetic

Suture Kit

What has been recalled in OVN lately?

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