OTSCneo System Set (100.03n-14n, 100.27n-31n)

• K Number: K251562
• Device Name: OTSCneo System Set (100.03n-14n, 100.27n-31n)
• Manufacturer: Ovesco Endoscopy AG
• Date Cleared: 2025-12-18 ( 210 days)
• Product Code: PKL
• Regulation Number: 876.4400
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

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.