Cleared Traditional

SONOCA II ULTRASONIC SURGICAL DEVICE (K901737) - FDA 510(k) Clearance

K901737 · Holl Meditronics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
77d
Days
-
Risk

K901737 is an FDA 510(k) clearance for the SONOCA II ULTRASONIC SURGICAL DEVICE. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Holl Meditronics, Inc. (Collingswood, US). The FDA issued a Cleared decision on July 3, 1990 after a review of 77 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 Holl Meditronics, Inc. devices

Submission Details

510(k) Number K901737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date July 03, 1990
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 156
Devices cleared under the same product code (LFL) and FDA review panel - the closest regulatory comparables to K901737.
CUSA® Clarity Ultrasonic Surgical Aspirator System
K251162 · Integra LifeSciences Corporation · Oct 2025
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10)
K242894 · Shanghai Saints Sages Surgical Co., Ltd. · Jun 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · Stryker Instruments · Mar 2025
Tenex 2nd Generation System
K241700 · Trice Medical, Inc. · Nov 2024
CUSA® Clarity Ultrasonic Surgical Aspirator System
K240493 · Integra LifeSciences Corporation · Jul 2024
Ultrasonic Surgical System
K233036 · Hunan Handlike Minimally Invasive Surgery Co., Ltd. · Jun 2024