(24 days)
The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.
The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel. The only change being proposed in this current Special 510(k) Premarket Notification is to convert the original latex rubber ligating bands to latex free rubber ligating bands. The Auto-Band Ligator incorporates the following product features: Automatic Reverse Movement to START position after each release. Snap Fixation system ensures stable fixation on the scope. Adjustable Snap Fixation System facilitates fixation on all brands of scopes. Precision One-Step Release Mechanism of bands. Only a single band can be released at a time. Latex Free Rubber Bands. Available in 5, 7 or 10 band configurations.
This document is a 510(k) Premarket Notification for the Scandimed International Auto-Band Ligator. The purpose of this notification is to introduce a material change from latex ligation bands to latex-free ligation bands.
As such, this document does not contain information related to acceptance criteria, specific device performance data in a quantifiable manner, sample sizes, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations. This submission is for a medical device that has undergone a material change (latex to latex-free bands) and is not an AI/ML powered device.
Therefore, the requested information cannot be extracted from the provided text.
§ 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.