Cleared Traditional

K042277 - SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM

K042277 · Integra Neurosciences, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
37d
Days
-
Risk

K042277 is an FDA 510(k) clearance for the SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Neurosciences, Ltd. (Andover Hampshire, GB). The FDA issued a Cleared decision on September 29, 2004 after a review of 37 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.

FDA 510(k) Submission Details - K042277

510(k) Number K042277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date September 29, 2004
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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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K042277 · SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
Download PDF FDA Summary Integra Neurosciences…