Leeches, Medicinal
NRN is the FDA product code for Leeches, Medicinal. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- NRN
- Device name
- Leeches, Medicinal
- FDA 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)
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 3
- Ingested recalls
- 0
Clearances, product code NRN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2014 | 1 |
| 2015 | 1 |
Applicants with the most clearances
Product code NRN| Applicant | Clearances |
|---|---|
| Biopharm UK Ltd | 1 |
| Carolina Biological Supply Co. | 1 |
| Ricarimpex SAS | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
