510(k)
BK251218: the device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification. This is 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.
FDA 510(k) · CAROLINA BIOLOGICAL SUPPLY COMPANY · decided May 16, 2025
Key facts
| 510(k) number | BK251218 |
|---|---|
| Device name | the device is a medicinal leech (hirudo medicinalis) belonging to the annelida worm classification. This is 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. |
| Applicant | CAROLINA BIOLOGICAL SUPPLY COMPANY |
| Product code | NRN |
| Date received | May 9, 2025 |
| Decision date | May 16, 2025 |
| Decision | substantially equivalent (SE) |
| Submission type | Special |
| Review panel | General & Plastic Surgery |
At a glance
- None MAUDE adverse event reports
- None Recall events
- None UDI device identifiers (GUDID)
- None Predicate devices cited
- None Later submissions citing this device
- 1–9 510(k)s with this product code
- No 510(k) summary on file
- No 510(k) statement on file
- Not listed On the FDA AI-enabled device list
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
Reading a 510(k)
- Decision
- SESE means the FDA found the device substantially equivalent to its predicate, so it may be marketed in the United States.
- Predicates
- Each clearance cites one or more legally marketed devices; the chain of predicates shows where a technology came from.
- Product code
- The three-letter code sets the device type, class and regulation, and groups competing clearances.
- Summary or statement
- Applicants file either a 510(k) summary of the safety and effectiveness information or a statement that it is available on request.
About 510(k) premarket notifications
A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database · Source date: