Submission Details
| 510(k) Number | K051036 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 2005 |
| Decision Date | June 02, 2005 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
Jun 2005
Decision
38d
Days
—
Risk
About This 510(k) Submission
K051036 is an FDA 510(k) clearance for the HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P, a Instrument, Ultrasonic Surgical, submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 2, 2005, 38 days after receiving the submission on April 25, 2005. This device falls under the General & Plastic Surgery review panel.
Device Classification
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |
Manufacturer
Similar Devices — LFL Instrument, Ultrasonic Surgical
All 156
K251162 · Integra LifeSciences Corporation
· Oct 2025
K242894 · Shanghai Saints Sages Surgical Co., Ltd.
· Jun 2025
K243930 · Stryker Instruments
· Mar 2025
K241700 · Trice Medical, Inc.
· Nov 2024
K240493 · Integra LifeSciences Corporation
· Jul 2024
K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd.
· Jun 2024
More from Ethicon Endo-Surgery, Inc.
View all
K141952
· GDW · Nov 2014
K111195
· GDW · Aug 2011
K110385
· GDW · Mar 2011
K101520
· GEI · Dec 2010
K102632
· GDW · Oct 2010