FDA product code OHG: Circumcision Tray

OHG is the FDA product code for circumcision tray. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. Devices under OHG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 20 recalls for OHG devices, 14 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 www.Fda.Gov/cdrh/ode/convkit.Html. 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 OHG devices

20 product recalls in 16 recall events; 14 initiated in the last five years and 14 still open. Most recent: 2026-05-21.

Frequently asked questions

What is FDA product code OHG?

OHG is the FDA product code for circumcision tray. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.

What device class is OHG?

Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k) exempt.

Have OHG devices been recalled?

Yes: 20 product recalls across 16 recall events; the most recent began 2026-05-21.

Next steps

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