FFP · Dilator, Rectal
Gastroenterology, Urology · 21 CFR 876.5450 · Class 1
Overview
| Product Code | FFP |
|---|---|
| Device Name | Dilator, Rectal |
| 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964634 | ANOKRYO | Mk Conquest Intl., Inc. | Jun 6, 1997 | SESE |
| K901426 | COLONIC BALLOON DILATOR | Telemed Systems, Inc. | Jun 21, 1990 | SESE |
| K894618 | INAMED RHEMO-D (TM) DILATOR | Inamed Development Co. | Jan 18, 1990 | SESE |
| K884713 | COLONIC BALLOON DIALATORS | Primrose Medical, Inc. | Sep 29, 1989 | SESE |
| K830354 | COLORECTAL DILATOR | Cleveland Medical Supply & Services | May 27, 1983 | SESE |
Top Applicants
- Cleveland Medical Supply & Services — 1 clearance
- Inamed Development Co. — 1 clearance
- Mk Conquest Intl., Inc. — 1 clearance
- Primrose Medical, Inc. — 1 clearance
- Telemed Systems, Inc. — 1 clearance
