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Found 3 results
510(k) Data Aggregation
K Number
K140907Device Name
LEECH, MEDICINAL
Manufacturer
CAROLINA BIOLOGICAL SUPPLY CO.
Date Cleared
2015-08-07
(486 days)
Product Code
NRN
Regulation Number
N/AWhy did this record match?
Product Code :
NRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medicinal leeches may be used in instances where skin flaps, skin grafts, surgical reattachments, or other tissues are adversely affected by impaired venous blood flow. Leeches may be used to alleviate the problem of venous congestion and delayed healing by creating prolonged localized bleeding.
Device Description
The Medicinal Leech is a laboratory-raised bloodsucking annelid (segmented worm) that inhabits fresh water. The leech has a cylindrical body, is slightly flattened, and has around 32 segments. It has a disc-shaped sucker at the head end and a tail sucker at the caudal end.
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K Number
K132958Device Name
MEDICINAL LEECHES
Manufacturer
BIOPHARM (UK) LTD.
Date Cleared
2014-02-19
(152 days)
Product Code
NRN
Regulation Number
N/AWhy did this record match?
Product Code :
NRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Leeches may be used in instances where skin flaps, skin grafts, or other tissues are suffering from impaired venous circulation. Leeches may be used to alleviate the problem of venous congestion by creating prolonged localized bleeding.
Device Description
The device is a European Medicinal Leech (Hirudo verbana). It is a greenish segmented worm of the Annelida worm classification. The animal is a bloodsucking animal living in freshwater.
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K Number
K040187Device Name
MEDICINAL LEECHES
Manufacturer
RICARIMPEX SAS
Date Cleared
2004-06-21
(145 days)
Product Code
NRN
Regulation Number
N/AWhy did this record match?
Product Code :
NRN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to when problems of venous congestion by creating prolonged localized bleeding.
Device Description
Medicinal Leeches, a blood sucking aquatic animal living in fresh water and subject to regulation by the U.S. Fish and Wildlife Service, are a preamendment, unclassified device which, by nature of their historical use and documented value in various post surgical situations.
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