Atlas FDA

PLASMA EDGE System

FDA 510(k) clearance K240504 · decided 2024-06-12

Clearance details

K-number
K240504
Device name
PLASMA EDGE System
Applicant
Lamidey Noury Medical
Decision
Substantially Equivalent
Date received
2024-02-21
Decision date
2024-06-12
Days to decision
112 days
Clearance type
Special
Product code
FAS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Verrières Le Buisson, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.