NVT · Tubing And Tubing/Filter Fits
Obstetrics/Gynecology · 21 CFR 884.1700 · Class 1
Overview
| Product Code | NVT |
|---|---|
| Device Name | Tubing And Tubing/Filter Fits |
| Regulation | 21 CFR 884.1700 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
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.
Classification Rationale
(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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
