Dilator, Rectal
The Rectal Dilator is a tapered instrument used to gradually dilate the rectal canal, typically in the management of anal strictures or in preparation for rectal procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket notification requirement. The product code is FFP, regulated under 21 CFR 876.5450, within the Gastroenterology, Urology medical specialty.
Basic Information
- Product Code
- FFP
- Device Class
- FDA class 1
- Regulation Number
- 876.5450
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K964634 | ANOKRYO | Jun 06, 1997 | Substantially Equivalent | Mk Conquest Intl., Inc. |
| K901426 | COLONIC BALLOON DILATOR | Jun 21, 1990 | Substantially Equivalent | Telemed Systems, Inc. |
| K894618 | INAMED RHEMO-D (TM) DILATOR | Jan 18, 1990 | Substantially Equivalent | Inamed Development Co. |
| K884713 | COLONIC BALLOON DIALATORS | Sep 29, 1989 | Substantially Equivalent | Primrose Medical, Inc. |
| K830354 | COLORECTAL DILATOR | May 27, 1983 | Substantially Equivalent | Cleveland Medical Supply & Services |
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.