FDA product code OVN: Suture Kit

OVN is the FDA product code for suture kit. It is a Class II device, regulated under 21 CFR 878.4830 and reviewed by the General and Plastic Surgery panel. Devices under OVN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 10 recalls for OVN devices, 3 initiated in the last five years.

Definition

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 if it meets all criteria in the guidance.

Classification

Recalls for OVN devices

10 product recalls in 4 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-03-09.

Frequently asked questions

What is FDA product code OVN?

OVN is the FDA product code for suture kit. It is a Class II device, regulated under 21 CFR 878.4830 and reviewed by the General and Plastic Surgery panel.

What device class is OVN?

Class II, regulation 21 CFR 878.4830. Typical premarket route: 510(k) exempt.

Have OVN devices been recalled?

Yes: 10 product recalls across 4 recall events; the most recent began 2026-03-09.

Next steps

• Run an FDA pathway report with predicate devices for product code OVN
• Run a recall and safety report across every OVN manufacturer
• Watch product code OVN for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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