FDA product code OIJ: Biopsy Needle Guide Kit
OIJ is the FDA product code for biopsy needle guide kit. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Radiology panel. Devices under OIJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for OIJ devices.
Definition
FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturers device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. 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
| Field | Value |
|---|---|
| Device name | Biopsy Needle Guide Kit |
| Device class | Class II |
| Regulation | 21 CFR 892.1560 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Recalls for OIJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-07-07.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code OIJ?
OIJ is the FDA product code for biopsy needle guide kit. It is a Class II device, regulated under 21 CFR 892.1560 and reviewed by the Radiology panel.
What device class is OIJ?
Class II, regulation 21 CFR 892.1560. Typical premarket route: 510(k) exempt.
Have OIJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2017-07-07.
Next steps
- Run an FDA pathway report with predicate devices for product code OIJ
- Run a recall and safety report across every OIJ manufacturer
- Watch product code OIJ 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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