510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970565Substantially Equivalent

Mammotome Biopsy Probe and Housing (Mammotome)

Biopsys Medical, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970565 is the FDA 510(k) clearance record for MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME), a class II device, cleared for Biopsys Medical, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list 15 510(k) clearances for Biopsys Medical, Inc., from to . As of , FDA records show no recalls naming K970565.

Clearance record

Decision date
Received
(43 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Biopsys Medical, Inc. #3 Morgan, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code KNW

Trailing 12 months
8 clearances under product code KNW in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code KNW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20260
August 20264
September 20260
October 20260