Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
NRNUnclassified

Leeches, Medicinal

Unknown

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 year
3 clearances under product code NRN with a decision year between 2004 and 2015, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NRN by decision year
YearClearances
20041
20141
20151

Applicants with the most clearances

Product code NRN
Applicants holding the most 510(k) clearances under product code NRN
ApplicantClearances
Biopharm UK Ltd1
Carolina Biological Supply Co.1
Ricarimpex SAS1

Companies listing this code with FDA

Companies whose registered establishments list this code