Product code KGW— General, Plastic Surgery
ALEXIS LAPAROSCOPIC SYSTEM
- Classification name
- Ring (Wound Protector), Drape Retention, Internal
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 9
- First cleared
- Most recent
Market context for product code KGW
FDA has cleared devices under product code KGW between 1979 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2013
- 2010
- 2009
- 2007
- 2004
- 1984
- 1979
Top applicants under product code KGW
Recent clearances under product code KGW
- K260982 — Alexis lighted wound protector-retractor, flexible, extra small (cl312) +6 more
- K253531 — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402) +1 more
- K113268 — ALEXIS O WOUND PROTECTOR/RETRACTOR
- K100120 — ALEXIS ORTHOPAEDIC WOUND RETRACTOR
- K093296 — ALEXIS LAPAROSCOPIC SYSTEM
- K062907 — ALEXIS WOUND RETRACTOR
- K041711 — ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
- K840946 — MICROPOROUS HYPOALLERGENIC
- K790306 — EDGE PROTECTOR, BARRIER
Data sourced from openFDA. This site is unofficial and independent of the FDA.