510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132958Substantially Equivalent

Medicinal Leeches

Biopharm UK Ltd, Hendy, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132958 is the FDA 510(k) clearance record for MEDICINAL LEECHES, cleared for Biopharm (Uk) , Ltd. on under FDA product code NRN (Leeches, Medicinal). FDA's definition for product code NRN 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...". FDA records list one 510(k) clearance for Biopharm (Uk) , Ltd. As of , FDA records show no recalls naming K132958.

Clearance record

Decision date
Received
(152 days to decision)
Product code
NRN Leeches, Medicinal
Device class
Unclassified
Review panel
Unknown
Applicant
Biopharm (Uk) , Ltd. 2 Bryngwili Rd., Hendy, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRN

Trailing 12 months

FDA records hold no clearances under product code NRN in the trailing twelve months.

FDA records show no clearances under product code NRN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NRN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260