Cleared Traditional

K250645 - SleeveLUX 24 Anoscope/Proctoscope (P2001)

Also marketed or referenced as:
SleeveLUX 16 Anoscope/Proctoscope (P2002)

K250645 is an FDA 510(k) clearance for SleeveLUX 24 Anoscope/Proctoscope (P2001), manufactured by Haemoband Surgical, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FER cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K250645 · Haemoband Surgical, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
219d
Days
Class 2
Risk

K250645 is an FDA 510(k) clearance for the SleeveLUX 24 Anoscope/Proctoscope (P2001). Classified as Anoscope And Accessories (product code FER), Class II - Special Controls.

Submitted by Haemoband Surgical, Ltd. (Belfast, GB). The FDA issued a Cleared decision on October 9, 2025 after a review of 219 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Haemoband Surgical, Ltd. devices

FDA 510(k) Submission Details - K250645

510(k) Number K250645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2025
Decision Date October 09, 2025
Days to Decision 219 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 130d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FER Device Classification - Class 2, Special Controls

Product Code FER Anoscope And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform Procedures Within The Anus And Rectum.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FER Anoscope And Accessories

All 11
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