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K Number
K183309
Device Name
stentfix OTSC System Set
Manufacturer
Ovesco Endoscopy AG
Date Cleared
2019-10-22

(327 days)

Product Code
PKL,OCZ
Regulation Number
876.4400
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Instrument for flexible endoscopy for fixation of metal stents in the gastrointestinal tract for use in adults only.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a medical device (stentfix OTSC System Set), not a study evaluating device performance or AI. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text.

The document is a clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and general controls, but not a specific performance study against acceptance criteria.

§ 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.