510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250645Substantially Equivalent

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

Haemoband Surgical Ltd, Belfast, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250645 is the FDA 510(k) clearance record for SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002), a class II device, cleared for Haemoband Surgical, Ltd. on under FDA product code FER (Anoscope And Accessories). FDA's definition for product code FER reads: "To examine and perform procedures within the anus and rectum". FDA records list 2 510(k) clearances for Haemoband Surgical, Ltd., from to . As of , FDA records show no recalls naming K250645.

Clearance record

Decision date
Received
(219 days to decision)
Product code
FER Anoscope And Accessories
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Haemoband Surgical, Ltd. The Mount Business Centre, Belfast, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FER

Trailing 12 months

FDA records hold no clearances under product code FER in the trailing twelve months.

FDA records show no clearances under product code FER in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FER, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260