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LEM Hemorrhoidal Ligator, Models A.5650, A.5660

by Sapimed S.P.A.

510(k) K070881

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K070881↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK070881 Date26 Sep 2007ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FHN
Device Class
Class II
Regulation
21 CFR Part 876.4400
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LEM Hemorrhoidal Ligator, Models A.5650 and A.5660, is a surgical device classified as a ligator, hemorrhoidal under the FDA nomenclature. It is designed to apply ligatures to hemorrhoidal tissue, facilitating the controlled occlusion and subsequent removal of prolapsed hemorrhoids during minimally invasive procedures. This device aids in the treatment of hemorrhoidal disease by providing a precise and efficient means of tissue ligation.

The LEM Hemorrhoidal Ligator is intended for use in outpatient surgical settings, endoscopy suites, or operating rooms by trained medical professionals. Supplied as a reusable device, it requires proper sterilization between uses in accordance with established protocols. The device is classified as Class II under the FDA and has received FDA 510K clearance, MDD, and MDR authorizations. Models A.5650 and A.5660 are distinct variants, each with specific mechanical configurations for clinical application.

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