Cleared Traditional

ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT (K102274) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K102274 · Arvik Enterprises/ Mini Lap Technologies · General & Plastic Surgery device
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Jun 2011
Decision
308d
Days
Class 1
Risk

K102274 is an FDA 510(k) clearance for the ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Arvik Enterprises/ Mini Lap Technologies (Shelton, US). The FDA issued a Cleared decision on June 15, 2011 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Arvik Enterprises/ Mini Lap Technologies devices

Submission Details

510(k) Number K102274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2010
Decision Date June 15, 2011
Days to Decision 308 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
193d slower than avg
Panel avg: 115d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GAA Needle, Aspiration And Injection, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.