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 Pro
| Device Type ID | 5951 |
| Device Name | Leeches, Medicinal |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | NRN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5951 |
| Device | Leeches, Medicinal |
| Product Code | NRN |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOPHARM (UK) LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAROLINA BIOLOGICAL SUPPLY CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 4 |
Device Issue | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 8 |