(83 days)
The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.
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This document is a 510(k) clearance letter from the FDA for a medical device called the "Pattison Esophageal Dilator." The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical performance data or studies that establish novel acceptance criteria. The focus is on comparing the new device's design, materials, indications for use, and performance characteristics to those of an already legally marketed device.
Therefore, I cannot extract the requested information from the provided text because it is not present.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). 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.