510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132612Substantially Equivalent

Harmonic Ace+ Shears 23 Cm Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 Cm Length with Advance

Ethicon Endo-Surgery Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132612 is the FDA 510(k) clearance record for HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE, cleared for Ethicon Endo-Surgery, LLC on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, LLC, from to . As of , FDA records show one recall naming K132612.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Ethicon Endo-Surgery, LLC 4545 Creek Rd., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFL

Trailing 12 months
1 clearance under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260