Home / 510(k) Clearances / K250645

510(k) K250645

SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) by Haemoband Surgical, Ltd. — Product Code FER

K250645 is an FDA 510(k) premarket notification submitted by Haemoband Surgical, Ltd. for the device "SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)". The FDA issued a decision of Substantially Equivalent on October 9, 2025. The device falls under product code FER (Anoscope And Accessories), a Class II device regulated under 21 CFR 876.1500. Haemoband Surgical, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2025
Date Received
March 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anoscope And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To examine and perform procedures within the anus and rectum.

Other clearances by Haemoband Surgical, Ltd.

  • K091519 — HAEMOBAND MULTI-LIGATOR (July 28, 2009)

Other clearances for product code FER

  • K242668 — Gastro Concepts Air Assist (December 13, 2024)
  • K230439 — WellCare Anoscope (December 22, 2023)
  • K200021 — Applied Medical Anoscope (January 6, 2021)
  • K171701 — GelPOINT Path Transanal Access Platform (July 20, 2017)
  • K133393 — GELPOINT PATH TRANSANAL ACCESS PLATFORM (January 2, 2014)
  • K133687 — THD N-ANO ANOSCOPE (December 11, 2013)
  • K121604 — ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT (July 27, 2012)
  • K121135 — THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE (June 1, 2012)
  • K110792 — GELPOINT PATH (May 23, 2011)
  • K103647 — THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES (March 1, 2011)

FDA data resources