NRN — Leeches, Medicinal Class U
FDA product code NRN covers "Leeches, Medicinal", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NRN
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- No
Definition
The device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification. The animal is a bloodsucking aquatic animal living in fresh water. The device should be indicated as: "an adjunct to the graft tissue healing when problems of venous congestion may delay healing, or to overcome the problem of venous congestion by creating prolonged localized bleeding." See Federal Register Notice at 89 FR 106521 Transfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Research; Medical Maggots and Medicinal Leeches (FRN) (FDA-2024-N-5702)