FDA product code PKE: Laparoscopic Cholecystectomy Kit

PKE is the FDA product code for laparoscopic cholecystectomy kit. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. Devices under PKE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for PKE devices, 1 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 http://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 PKE devices

2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-02.

Frequently asked questions

What is FDA product code PKE?

PKE is the FDA product code for laparoscopic cholecystectomy kit. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.

What device class is PKE?

Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.

Have PKE devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2022-11-02.

Next steps

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