Cleared Traditional

RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A (K062642) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K062642 · Rf Surgical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
57d
Days
Class 1
Risk

K062642 is an FDA 510(k) clearance for the RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A. Classified as Counter, Sponge, Surgical (product code LWH), Class I - General Controls.

Submitted by Rf Surgical Systems, Inc. (Bellevue, US). The FDA issued a Cleared decision on November 2, 2006 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.2740 - the FDA general and plastic surgery device framework. 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 Rf Surgical Systems, Inc. devices

Submission Details

510(k) Number K062642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2006
Decision Date November 02, 2006
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWH Counter, Sponge, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.