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The Tracker / October 2025 / K250645

510(k) cleared

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

Haemoband Surgical, Ltd. · Oct 9, 2025 · K250645

FDA cleared the SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) from Haemoband Surgical, Ltd. on Oct 9, 2025 under K250645, a traditional 510(k). The device falls under product code FER, Anoscope And Accessories, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 4, 2025. The decision came 219 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Haemoband Surgical, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250645?

K250645 is the FDA 510(k) for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002), submitted by Haemoband Surgical, Ltd.. FDA's decision date was Oct 9, 2025, under product code FER (Anoscope And Accessories).

Who makes the SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)?

Haemoband Surgical, Ltd., based in Belfast, is the applicant of record for K250645.

How long did the K250645 review take?

FDA received the submission on Mar 4, 2025 and issued its decision on Oct 9, 2025, 219 days later.

← All decisions in October 2025