K250645

Substantially Equivalent

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

Applicant: Haemoband Surgical, Ltd.
Product code: FER
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.