FHN · Ligator, Hemorrhoidal
Gastroenterology, Urology · 21 CFR 876.4400 · Class 2
Overview
| Product Code | FHN |
|---|---|
| Device Name | Ligator, Hemorrhoidal |
| Regulation | 21 CFR 876.4400 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
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.
Cleared Devices (22)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | Jun 6, 2022 | SESE |
| K172985 | Ligation Device | Leo Medical Co., Ltd. | Jun 14, 2018 | SESE |
| K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | Jun 12, 2015 | SESE |
| K131282 | NEXUS HEMORRHOID LIGATOR | Inx Medical | Jul 11, 2013 | SESE |
| K093497 | THD BANDY | Thd Spa | Jul 15, 2010 | SESE |
| K091519 | HAEMOBAND MULTI-LIGATOR | Haemoband Surgical, Ltd. | Jul 28, 2009 | SESE |
| K070881 | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | Sapimed S.P.A. | Sep 26, 2007 | SESE |
| K020824 | SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 | Boston Scientific Corp | Apr 12, 2002 | SESE |
| K020526 | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR | Don Wilson/Wilson-Cook Medical, Inc. | Mar 19, 2002 | SESE |
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | R-Med, Inc. | Jul 17, 2000 | SESE |
| K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER | Erchinger Medizintecnik | Apr 24, 2000 | SESE |
| K000397 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL | Boston Scientific Corp | Mar 7, 2000 | SESE |
| K981669 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR | Boston Scientific Corp | Jun 4, 1998 | SESE |
| K974018 | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR | Wilson-Cook Medical, Inc. | Jan 20, 1998 | SESE |
| K963166 | O'REGAN LIGATOR | Patrick J. O'Regan | May 5, 1997 | SESE |
| K964079 | SPEEDBAND MULTIPLE BAND LIGATOR | Boston Scientific Corp | Feb 13, 1997 | SESE |
| K960020 | SOLO BAND LIGATOR | Surcraft, LLC | Apr 1, 1996 | SESE |
| K952262 | SPEEDBAND | Boston Scientific Corp | Feb 29, 1996 | SESE |
| K882297 | 1/2 CM REAR TIP EXTENDER (RTE) | American Medical Systems, Inc. | Jun 17, 1988 | SESE |
| K880648 | ENDOSCOPIC ELASTIC BAND LIGATOR | Superior Healthcare Group, Inc. | Apr 6, 1988 | SESE |
| K832192 | SUCTION-HEMORRHOID-LIGATOR | Research Endoscope Systems Intl. | Dec 27, 1983 | SESE |
| K801352 | HEMORRHOIDAL LIGATION INSTR. SYSTEM | Depuy, Inc. | Jul 8, 1980 | SESE |
Top Applicants
- Boston Scientific Corp — 5 clearances
- Wilson-Cook Medical, Inc. — 1 clearance
- Thd Spa — 1 clearance
- Surcraft, LLC — 1 clearance
- Superior Healthcare Group, Inc. — 1 clearance
