510(K) CLEARANCES 63 ▲12RECALLS POSTED 17 ▼8CLASS I 1PMA DECISIONS 48 ▼2WEEK ENDING / FDA DATA AS OF
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K991980Substantially Equivalent

Mammotome Hh Hand-Held Probe, Vacuum Set, Control Module, Hh Hand-Held Holster and Cables, Software Package, Footswitch,

Ethicon Endo-Surgery Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991980 is the FDA 510(k) clearance record for MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,, a class II device, cleared for Ethicon Endo-Surgery, Inc. on under FDA product code KNW (Instrument, Biopsy). FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, Inc., from to . As of , FDA records show no recalls naming K991980.

Clearance record

Decision date
Received
(64 days to decision)
Product code
KNW Instrument, Biopsy
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Ethicon Endo-Surgery, Inc. 4545 Creek Rd., Cincinnati OH
510(k) summary
Summary
Third party review
No

Clearances, product code KNW

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