Class Class II

OTSCneo System Set (100.03n-14n, 100.27n-31n) (K251562)

K251562 2025-12-18 Traditional
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Description

OTSCneo System Set (100.03n-14n, 100.27n-31n) by Ovesco Endoscopy AG, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251562
Clearance Date2025-12-18
Clearance TypeTraditional
Product CodePKL
Regulation Number876.4400

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