ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER

• K Number: K000297
• Device Name: ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
• Manufacturer: ERCHINGER MEDIZINTECNIK
• Date Cleared: 2000-04-24 ( 84 days)
• Product Code: FHN
• Regulation Number: 876.4400
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: N/A
• Predicate For: K070881

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.