FDA product code OHD: Gynecological Laparoscopic Kit

OHD is the FDA product code for gynecological laparoscopic kit. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel. Devices under OHD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 55 recalls for OHD devices, 44 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 OHD devices

55 product recalls in 44 recall events; 44 initiated in the last five years and 45 still open. Most recent: 2026-08-18.

Frequently asked questions

What is FDA product code OHD?

OHD is the FDA product code for gynecological laparoscopic kit. It is a Class II device, regulated under 21 CFR 884.1720 and reviewed by the Obstetrics and Gynecology panel.

What device class is OHD?

Class II, regulation 21 CFR 884.1720. Typical premarket route: 510(k) exempt.

Have OHD devices been recalled?

Yes: 55 product recalls across 44 recall events; the most recent began 2026-08-18.

Next steps

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