Cleared Traditional

K093296 - ALEXIS LAPAROSCOPIC SYSTEM

K093296 is an FDA 510(k) clearance for ALEXIS LAPAROSCOPIC SYSTEM, manufactured by Applied Medical Resources Corp.. The device is a Class 2 General & Plastic Surgery device with product code KGW cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K093296 · Applied Medical Resources Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
15d
Days
Class 2
Risk

K093296 is an FDA 510(k) clearance for the ALEXIS LAPAROSCOPIC SYSTEM. Classified as Ring (wound Protector), Drape Retention, Internal (product code KGW), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on November 5, 2009 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - 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 Applied Medical Resources Corp. devices

FDA 510(k) Submission Details - K093296

510(k) Number K093296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2009
Decision Date November 05, 2009
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KGW Device Classification - Class 2, Special Controls

Product Code KGW Ring (wound Protector), Drape Retention, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGW Ring (wound Protector), Drape Retention, Internal

All 7
Devices cleared under the same product code (KGW) and FDA review panel - the closest regulatory comparables to K093296.
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402)
K253531 · Applied Medical Resources Corporation · Feb 2026
ALEXIS O WOUND PROTECTOR/RETRACTOR
K113268 · Applied Medical Resources Corp. · Feb 2013
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
K100120 · Applied Medical Resources Corp. · Apr 2010
ALEXIS WOUND RETRACTOR
K062907 · Applied Medical Resources · Jan 2007
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
K041711 · Applied Medical Resources Corp. · Aug 2004
EDGE PROTECTOR, BARRIER
K790306 · Surgikos, Inc. · Feb 1979

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.