Atlas FDA

KGW

9 FDA 510(k) clearances · Product code

77 daysmedian time to decision
462 days90th percentile
9clearances measured

FDA profile

Official device name
Ring (Wound Protector), Drape Retention, Internal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4370
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2016: 12 · 2017: 58 · 2018: 13 · 2020: 12 · 2022: 18 · 2024: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) (K260982)Applied Medical Resources Corporation2026-04-24
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (K253531)Applied Medical Resources Corporation2026-02-23
ALEXIS O WOUND PROTECTOR/RETRACTOR (K113268)Applied Medical Resources Corp.2013-02-08
ALEXIS ORTHOPAEDIC WOUND RETRACTOR (K100120)Applied Medical Resources Corp.2010-04-02
ALEXIS LAPAROSCOPIC SYSTEM (K093296)Applied Medical Resources Corp.2009-11-05
ALEXIS WOUND RETRACTOR (K062907)Applied Medical Resources2007-01-09
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 (K041711)Applied Medical Resources Corp.2004-08-26
MICROPOROUS HYPOALLERGENIC (K840946)Gainor Medical1984-08-17
EDGE PROTECTOR, BARRIER (K790306)Surgikos, Inc.1979-02-22

Track KGW automatically

Every clearance here is in the API, with alerts when new ones post.