PSJ · Rectal Dilator Kit
Gastroenterology, Urology · 21 CFR 876.5450 · Class 1
Overview
| Product Code | PSJ |
|---|---|
| Device Name | Rectal Dilator Kit |
| Regulation | 21 CFR 876.5450 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.
Classification Rationale
Class I (general 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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
