510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232262Substantially Equivalent

LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )

Surgease Innovations Ltd, Lancashire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232262 is the FDA 510(k) clearance record for LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ), a class II device, cleared for Surgease Innovations Limited on under FDA product code FAN (Sigmoidoscope, Rigid, Electrical). FDA records list one 510(k) clearance for Surgease Innovations Limited. As of , FDA records show no recalls naming K232262.

Clearance record

Decision date
Received
(122 days to decision)
Product code
FAN Sigmoidoscope, Rigid, Electrical
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Surgease Innovations Limited Pendle Innovation Centre, Brook St., Lancashire, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FAN

Trailing 12 months

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

FDA records show no clearances under product code FAN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FAN, 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