Class Class II

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) (K250645)

K250645 2025-10-09 Traditional
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Description

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) by Haemoband Surgical, Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250645
Clearance Date2025-10-09
Clearance TypeTraditional
Product CodeFER
Regulation Number876.1500

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