HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE— 510(k) K132612
Substantially EquivalentEthicon Endo-Surgery, LLC
FDA 510(k) clearance K132612 for HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE, Substantially Equivalent on 2013-10-17. Applicant: Ethicon Endo-Surgery, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Ethicon Endo-Surgery, LLC
- Product code
- Product code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code LFL
view all- K261361 — TORUS Ultrasonic Aspirator System +1 more
- K262244 — Sonopet iQ Series III Console (5700-050-000) +6 more
- K261448 — neXus Ultrasonic Surgical Aspirator System
- K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System
- K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more
More clearances from Ethicon Endo-Surgery, LLC
view all- K254196 — HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
- K260196 — ETHICON Circular Stapler (CDH21mm) +7 more
- K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
- K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more
- K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more
Adverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K132612
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132612.
Data sourced from openFDA. This site is unofficial and independent of the FDA.