Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Haemoband Surgical, Ltd.. It received FDA 510(k) clearance on 2025-10-09 under approval 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. It is manufactured by Haemoband Surgical, Ltd.. The 510(k) number is K250645.

When was SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) approved by the FDA?

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

What company makes SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)?

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) is manufactured by Haemoband Surgical, Ltd..

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)

K171701GelPOINT Path Transanal Access PlatformApplied Medical Resources Corp. K200021Applied Medical AnoscopeApplied Medical Resources K230439WellCare AnoscopeWell Care (Wuhan) Medical Technology Co., Ltd. K242668Gastro Concepts Air AssistGastro Concepts, LLC

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.

↑