SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
Device Facts
| Record ID | K000397 |
|---|---|
| Device Name | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL |
| Applicant | Boston Scientific Corp |
| Product Code | FHN · Gastroenterology, Urology |
| Decision Date | Mar 7, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
