(198 days)
The Karl Storz model 203020 20 Equimat system is designed to monitor the inflow and outflow of irrigation fluid from the uterus during endoscopic surgical procedures in gynecology.
The Karl Storz model 203020 20 Equimat is a microprocessor controlled monitoring device designed to be used in conjunction with irrigation/aspiration systems to monitor the volume of irrigation fluid flowing into and out of the uterus during endoscopic surgical procedures in gynecology.
This document is a 510(k) Summary of Safety and Effectiveness for the Karl Storz Model 203020 20 Equimat, a fluid monitoring system. It declares substantial equivalence to predicate devices but does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided document is a regulatory submission, not a study report. Therefore, I cannot extract the requested information.
§ 884.1700 Hysteroscopic insufflator.
(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.