Cleared Traditional

K962584 - ULTRACISION 5MM HARD SHEATH LAPAROSONIC...

K962584 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
126d
Days
-
Risk

K962584 is an FDA 510(k) clearance for the ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 4, 1996 after a review of 126 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K962584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date November 04, 1996
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 115d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 67
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K962584.
ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE
K971302 · Ethicon Endo-Surgery, Inc. · Jul 1997
ULTRASONIC HAND INSTRUMENTS
K971861 · United States Surgical, A Division of Tyco Healthc · Jul 1997
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
K964601 · Valleylab, Inc. · Jan 1997
SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE
K960040 · Sharplan Lasers, Inc. · Apr 1996
CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS
K934628 · Valleylab, Inc. · Jul 1995
COOPER LASER SONICS CUSA MODEL 200
K950945 · Valleylab, Inc. · Apr 1995