510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813081Substantially Equivalent

Histocan Biopsy Needle

Burron Medical Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813081 is the FDA 510(k) clearance record for HISTOCAN BIOPSY NEEDLE, cleared for Burron Medical Products, Inc. on . FDA records list 41 510(k) clearances for Burron Medical Products, Inc., from to . As of , FDA records show no recalls naming K813081.

Clearance record

Decision date
Received
(57 days to decision)
Review panel
Unknown
Applicant
Burron Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No