FDA product code OJF: Hysterectomy Kit

OJF is the FDA product code for hysterectomy kit. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. Devices under OJF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 29 recalls for OJF devices, 27 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 OJF devices

29 product recalls in 28 recall events; 27 initiated in the last five years and 27 still open. Most recent: 2026-08-18.

Frequently asked questions

What is FDA product code OJF?

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

What device class is OJF?

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

Have OJF devices been recalled?

Yes: 29 product recalls across 28 recall events; the most recent began 2026-08-18.

Next steps

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