HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE

• K Number: K013066
• Device Name: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
• Manufacturer: OLYMPUS AMERICA, INC.
• Date Cleared: 2001-12-11 ( 90 days)
• Product Code: MND , FHN
• Regulation Number: 876.4400
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: K963160 , K990687

Intended Use

The HX-5/6-1 Clip Fixing Devices are intended to be used with an Olympus endoscope for the purpose of:
(1) endoscopic marking,
(2) hemostasis for
(a) mucosal/sub-mucosal defects

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. While it describes the device's intended use and provides a comparison to predicate devices, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies.

Therefore, I cannot extract the requested information from the given text.

The document discusses:

• Device Name: Rotatable Clip Fixing Devices HX-5/6-1
• Manufacturer: Olympus Optical Co., Ltd.
• Regulation Number: 21 CFR 876.4400 (Hemorrhoidal Ligator, Class II)
• Intended Use: Endoscopic marking, hemostasis (for mucosal/sub-mucosal defects, bleeding ulcers, arteries

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.