Cleared Traditional

K893926 - SONOCA ULTRASONIC SURGICAL SYSTEM

K893926 · Holl Meditronics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
167d
Days
-
Risk

K893926 is an FDA 510(k) clearance for the SONOCA ULTRASONIC SURGICAL SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Holl Meditronics, Inc. (Bolton, Ontario, CA). The FDA issued a Cleared decision on November 14, 1989 after a review of 167 days - an extended review 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: 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 Holl Meditronics, Inc. devices

FDA 510(k) Submission Details - K893926

510(k) Number K893926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1989
Decision Date November 14, 1989
Days to Decision 167 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 115d · This submission: 167d
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 89
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K893926.
CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR
K921251 · Valleylab, Inc. · Jun 1992
CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR
K910696 · Valleylab, Inc. · Jun 1991
CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR
K894600 · Valleylab, Inc. · Jan 1990
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS
K883091 · Sharplan Lasers, Inc. · Oct 1988
CUSA SYSTEM 200 MACRO-DISSECTOR
K864983 · Cooper Lasersonics, Inc. · Jun 1987
R PAK
K851203 · CooperVision, Inc. · Jul 1985