FHN — Ligator, Hemorrhoidal Class II
FDA product code FHN covers "Ligator, Hemorrhoidal", a Class II medical device regulated under 21 CFR 876.4400. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FHN
- Device Class
- Class II
- Regulation Number
- 876.4400
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K213223 | beijing zksk technology co | Multi-Band Ligator | June 6, 2022 |
| K172985 | leo medical co | Ligation Device | June 14, 2018 |
| K150718 | agency for medical innovations | Wi-3 HAL-RAR System | June 12, 2015 |
| K131282 | inx medical | NEXUS HEMORRHOID LIGATOR | July 11, 2013 |
| K093497 | thd | THD BANDY | July 15, 2010 |
| K091519 | haemoband surgical | HAEMOBAND MULTI-LIGATOR | July 28, 2009 |
| K070881 | sapimed | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | September 26, 2007 |
| K020824 | boston scientific | SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 | April 12, 2002 |
| K020526 | don wilson/wilson-cook medical | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR | March 19, 2002 |
| K001236 | r-med | RIZA BAND STRETCHER (RBS)-60000 | July 17, 2000 |
| K000297 | erchinger medizintecnik | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNE | April 24, 2000 |
| K000397 | boston scientific | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAN | March 7, 2000 |
| K981669 | boston scientific | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR | June 4, 1998 |
| K974018 | wilson-cook medical | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR | January 20, 1998 |
| K963166 | patrick j. o'regan | O'REGAN LIGATOR | May 5, 1997 |
| K964079 | boston scientific | SPEEDBAND MULTIPLE BAND LIGATOR | February 13, 1997 |
| K960020 | surcraft | SOLO BAND LIGATOR | April 1, 1996 |
| K952262 | boston scientific | SPEEDBAND | February 29, 1996 |
| K882297 | american medical systems | 1/2 CM REAR TIP EXTENDER (RTE) | June 17, 1988 |
| K880648 | superior healthcare group | ENDOSCOPIC ELASTIC BAND LIGATOR | April 6, 1988 |