Cleared Traditional

K023173 - ANDREWS INTRODUCER, MODEL ASI01

K023173 is an FDA 510(k) clearance for ANDREWS INTRODUCER, manufactured by Andrews Surgical Innovations, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K023173 · Andrews Surgical Innovations, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
86d
Days
Class 1
Risk

K023173 is an FDA 510(k) clearance for the ANDREWS INTRODUCER, MODEL ASI01. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Andrews Surgical Innovations, Ltd. (Co. Dublin, IE). The FDA issued a Cleared decision on December 18, 2002 after a review of 86 days - a notably fast clearance cycle.

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: 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 Andrews Surgical Innovations, Ltd. devices

FDA 510(k) Submission Details - K023173

510(k) Number K023173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2002
Decision Date December 18, 2002
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

Product Code MDM Instrument, Manual, Surgical, General Use
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.

Regulatory Peers - MDM Instrument, Manual, Surgical, General Use

All 11
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K023173.
MICROVASIVE PULMONARY GUIDEWIRE
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K930399 · O.R. Concepts, Inc. · Feb 1993
LACERATION REPAIR TRAY
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