FDA product code NRN: Leeches, Medicinal
NRN is the FDA product code for leeches, medicinal. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under NRN, from 3 different applicants. The average 510(k) review took 261 days (median 152).
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)
Classification
| Field | Value |
|---|---|
| Device name | Leeches, Medicinal |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NRN clearance
Top NRN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carolina Biological Supply Co. | 1 | 2015-08-07 |
| Biopharm (Uk) , Ltd. | 1 | 2014-02-19 |
| Ricarimpex Sas | 1 | 2004-06-21 |
Most recent NRN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140907 | Carolina Biological Supply Co. | LEECH, MEDICINAL | 2015-08-07 | 486 |
| K132958 | Biopharm (Uk) , Ltd. | MEDICINAL LEECHES | 2014-02-19 | 152 |
| K040187 | Ricarimpex Sas | MEDICINAL LEECHES | 2004-06-21 | 145 |
Recalls for NRN devices
openFDA lists no recalls for product code NRN.
Frequently asked questions
What is FDA product code NRN?
NRN is the FDA product code for leeches, medicinal. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is NRN?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRN?
Across 3 cleared submissions the average was 261 days from receipt to decision (median 152).
Which companies have the most NRN clearances?
Carolina Biological Supply Co. (1); Biopharm (Uk) , Ltd. (1); Ricarimpex Sas (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NRN
- Run a recall and safety report across every NRN manufacturer
- Watch product code NRN 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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