(242 days)
The Maloney and Hurst Bougies indications for use are for the dilation of: 1 - Upper esophageal webs. 2 - Lower esophageal rings. 3 - Caustic strictures. 4 - Peptic esophageal strictures. 5 - Temporary ease of esophageal carcinoma.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Tungsten Filled Maloney and Hurst Bougies." It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The letter primarily states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
The "Indications For Use" section lists the medical conditions the device is intended to treat, but this is distinct from acceptance criteria or performance study results.
§ 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.