Cleared Traditional

K933239 - CV720-727-000

K933239 · Valleylab, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
102d
Days
-
Risk

K933239 is an FDA 510(k) clearance for the CV720-727-000, MICROTIP AND FLUE PAK. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 102 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 Valleylab, Inc. devices

FDA 510(k) Submission Details - K933239

510(k) Number K933239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1993
Decision Date October 12, 1993
Days to Decision 102 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
13d faster than avg
Panel avg: 115d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

LFL Device Classification - Class 0,

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

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