510(k) K132958
K132958 is an FDA 510(k) premarket notification submitted by Biopharm (Uk) , Ltd. for the device "MEDICINAL LEECHES". The FDA issued a decision of Substantially Equivalent on Feb 19, 2014. The device falls under product code NRN (Leeches, Medicinal), a Class U device.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 19, 2014
- Date Received
- Sep 20, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Leeches, Medicinal
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)
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)