NRN · Leeches, Medicinal
· Class U
Overview
| Product Code | NRN |
|---|---|
| Device Name | Leeches, Medicinal |
| Device Class | Class U |
| Review Panel |
Identification
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)
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140907 | LEECH, MEDICINAL | Carolina Biological Supply Co. | Aug 7, 2015 | SESE |
| K132958 | MEDICINAL LEECHES | Biopharm (Uk) , Ltd. | Feb 19, 2014 | SESE |
| K040187 | MEDICINAL LEECHES | Ricarimpex Sas | Jun 21, 2004 | SESE |
Top Applicants
- Biopharm (Uk) , Ltd. — 1 clearance
- Carolina Biological Supply Co. — 1 clearance
- Ricarimpex Sas — 1 clearance
