Leeches, Medicinal
Medicinal Leeches (Hirudo medicinalis) are aquatic, bloodsucking annelid worms used as an adjunct to graft tissue healing, particularly to overcome venous congestion by creating prolonged localized bleeding. They are indicated when venous congestion may delay healing following surgical procedures. This device is currently unclassified (Class U) by the FDA, and regulatory responsibility has been transferred from CDRH to the Center for Biologics Evaluation and Research (CBER) per Federal Register Notice at 89 FR 106521. The product code is NRN, reviewed by the General Surgery panel, and the unclassified reason is coded as 1.
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Basic Information
- Product Code
- NRN
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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)
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K140907 | LEECH, MEDICINAL | Aug 07, 2015 | Substantially Equivalent | Carolina Biological Supply Co. |
| K132958 | MEDICINAL LEECHES | Feb 19, 2014 | Substantially Equivalent | Biopharm (Uk) , Ltd. |
| K040187 | MEDICINAL LEECHES | Jun 21, 2004 | Substantially Equivalent | Ricarimpex Sas |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.