Hemoclip (511 series, 543 series)
Device Facts
| Record ID | K254069 |
|---|---|
| Device Name | Hemoclip (511 series, 543 series) |
| Applicant | Hangzhou AGS MedTech Co., Ltd. |
| Product Code | PKL · Gastroenterology, Urology |
| Decision Date | Aug 10, 2026 |
| 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.
