OLYMPUS ENDOSCOPIC LIGATION DEVICE
Device Facts
| Record ID | K001744 |
|---|---|
| Device Name | OLYMPUS ENDOSCOPIC LIGATION DEVICE |
| Applicant | Olympus America, Inc. |
| Product Code | MND · Gastroenterology, Urology |
| Decision Date | Feb 27, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.
Special Controls
*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, 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.
