SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)— 510(k) K250645

Name: FDA 510(k) clearance K250645
Creator: U.S. Food and Drug Administration
Published: 2025-10-09

Substantially Equivalent

Haemoband Surgical, Ltd.

FDA 510(k) clearance K250645 for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002), Substantially Equivalent on 2025-10-09. Applicant: Haemoband Surgical, Ltd.. Device class: 2.

Clearance details

Applicant: Haemoband Surgical, Ltd.
Product code: Code FER
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2025-03-04
Decision date: 2025-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Belfast, GB

Download summary PDF View on FDA.gov ↗

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