21 CFR 876.4400 — Ligator, Hemorrhoidal
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4400
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FHN | Ligator, Hemorrhoidal | 2 | 22 | |
| MND | Ligator, Esophageal | 2 | 15 | |
| PKL | Hemostatic Metal Clip For The Gi Tract | 2 | 62 | Implant, Life-Sustaining |
Special Controls
FHN — Ligator, Hemorrhoidal
*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.
eCFR
MND — Ligator, Esophageal
*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.
eCFR
PKL — Hemostatic Metal Clip For The Gi Tract
*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.
eCFR
