Product code FHN
- Device name
- Ligator, Hemorrhoidal
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4400
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | 2022-06-06 |
| K172985 | Ligation Device | Leo Medical Co., Ltd. | 2018-06-14 |
| K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015-06-12 |
| K131282 | NEXUS HEMORRHOID LIGATOR | Inx Medical | 2013-07-11 |
| K093497 | THD BANDY | Thd Spa | 2010-07-15 |
| K091519 | HAEMOBAND MULTI-LIGATOR | Haemoband Surgical, Ltd. | 2009-07-28 |
| K070881 | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | Sapimed S.P.A. | 2007-09-26 |
| K020824 | SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 | Boston Scientific Corp | 2002-04-12 |
| K020526 | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR | Don Wilson/Wilson-Cook Medical, Inc. | 2002-03-19 |
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | R-Med, Inc. | 2000-07-17 |
| K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER | Erchinger Medizintecnik | 2000-04-24 |
| K000397 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL | Boston Scientific Corp | 2000-03-07 |
| K981669 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR | Boston Scientific Corp | 1998-06-04 |
| K974018 | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR | Wilson-Cook Medical, Inc. | 1998-01-20 |
| K963166 | O'REGAN LIGATOR | Patrick J. O'Regan | 1997-05-05 |
| K964079 | SPEEDBAND MULTIPLE BAND LIGATOR | Boston Scientific Corp | 1997-02-13 |
| K960020 | SOLO BAND LIGATOR | Surcraft, LLC | 1996-04-01 |
| K952262 | SPEEDBAND | Boston Scientific Corp | 1996-02-29 |
| K882297 | 1/2 CM REAR TIP EXTENDER (RTE) | American Medical Systems, Inc. | 1988-06-17 |
| K880648 | ENDOSCOPIC ELASTIC BAND LIGATOR | Superior Healthcare Group, Inc. | 1988-04-06 |
| K832192 | SUCTION-HEMORRHOID-LIGATOR | Research Endoscope Systems Intl. | 1983-12-27 |
| K801352 | HEMORRHOIDAL LIGATION INSTR. SYSTEM | Depuy, Inc. | 1980-07-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033638801710 | Self-Suction-LEM | SAPI MED SPA | 2026-02-06 |
| 16934415066621 | ZKSK | Beijing ZKSK Technology Co.,Ltd | 2024-12-06 |
| 16934415066638 | ZKSK | Beijing ZKSK Technology Co.,Ltd | 2024-12-06 |
| 16934415066676 | ZKSK | Beijing ZKSK Technology Co.,Ltd | 2024-12-06 |
| 16934415066669 | ZKSK | Beijing ZKSK Technology Co.,Ltd | 2024-12-06 |
| 16934415066652 | ZKSK | Beijing ZKSK Technology Co.,Ltd | 2024-12-06 |
| 16934415066645 | ZKSK | Beijing ZKSK Technology Co.,Ltd | 2024-12-06 |
| 08033638801673 | LEM | SAPI MED SPA | 2023-07-27 |
| 08033638802328 | LEM | SAPI MED SPA | 2023-07-27 |
| 08033638803301 | Self-Suction-LEM | SAPI MED SPA | 2023-07-27 |
| 14026704736703 | PILLING | TELEFLEX INCORPORATED | 2021-02-12 |
| 14026704656094 | PILLING | TELEFLEX INCORPORATED | 2020-12-21 |
| 17540192000018 | CRH O'Regan System | CRH Medical Corporation | 2020-10-01 |
| 34026704651604 | PILLING | TELEFLEX INCORPORATED | 2020-04-23 |
| 00192896044685 | LATEX O-RINGS | SONTEC INSTRUMENTS, INC. | 2018-09-07 |
| 00192896044678 | MCGIVNEY HEMORRHOIDAL LIGATOR | SONTEC INSTRUMENTS, INC. | 2018-09-06 |
| 10653405005469 | SPACEBANDER | Conmed Corporation | 2018-04-10 |
| 08033737712153 | THD Bandy | THD SPA | 2017-01-18 |
| 10381780159988 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-12-29 |
| 08033638800287 | Haemorrhoid ligator | SAPI MED SPA | 2016-11-25 |
| 08033638800300 | Haemorrhoid ligator | SAPI MED SPA | 2016-11-25 |
| 08033737710685 | THD Bandy | THD SPA | 2016-10-07 |
| 10653405053637 | STIEGMANN-GOFF | Conmed Corporation | 2016-09-24 |
| 08714729201953 | Speedband Superview Super 7 | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 30653405053679 | STEIGMANN-GOFF BANDITO | Conmed Corporation | 2016-09-24 |
| 10381780176947 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-25 |
| 10381780160007 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-25 |
| 10381780159995 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-25 |
| 10381780159971 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780159964 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |