Cleared Traditional

K962525 - ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM

K962525 · Morwel Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
84d
Days
-
Risk

K962525 is an FDA 510(k) clearance for the ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Morwel Corp. (Tucson, US). The FDA issued a Cleared decision on September 19, 1996 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Morwel Corp. devices

FDA 510(k) Submission Details - K962525

510(k) Number K962525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1996
Decision Date September 19, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 133
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K962525.
RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM
K964742 · Aziz Y. Anis, M.D. · Apr 1997
CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY
K964601 · Valleylab, Inc. · Jan 1997
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
K962584 · Ethicon Endo-Surgery, Inc. · Nov 1996
ULTRACUT 2000
K960374 · Ultralase Technologies, Inc. · Jun 1996
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