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FDA 510(k)

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

K-Number: K250645 · 2025-10-09

ApplicantHaemoband Surgical, Ltd.
Decision Date2025-10-09
Product CodeFER
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) is the device name listed in this FDA 510(k) record. The listed applicant is Haemoband Surgical, Ltd.. It received FDA 510(k) clearance on 2025-10-09 under 510(k) number K250645. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)?

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Haemoband Surgical, Ltd.. The 510(k) number is K250645.

When did SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) receive FDA 510(k) clearance?

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K250645.

Who is the listed applicant for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)?

The FDA 510(k) record lists Haemoband Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)?

The FDA product code for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) is FER.

Related Devices (Code: FER)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242668Gastro Concepts Air AssistGastro Concepts, LLCK230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd.K200021Applied Medical AnoscopeApplied Medical ResourcesK171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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