Product code FHN— Gastroenterology, Urology
1/2 CM REAR TIP EXTENDER (RTE)
- Classification name
- Ligator, Hemorrhoidal
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 22
- First cleared
- Most recent
Market context for product code FHN
FDA has cleared devices under product code FHN between 1980 and 2022, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2018
- 2015
- 2013
- 2010
- 2009
- 2007
- 2002
- 2000
- 1998
- 1997
- 1996
- 1988
- 1983
- 1980
Top applicants under product code FHN
Recent clearances under product code FHN
- K213223 — Multi-Band Ligator
- K172985 — Ligation Device
- K150718 — Wi-3 HAL-RAR System
- K131282 — NEXUS HEMORRHOID LIGATOR
- K093497 — THD BANDY
- K091519 — HAEMOBAND MULTI-LIGATOR
- K070881 — LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
- K020824 — SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
- K020526 — MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
- K001236 — RIZA BAND STRETCHER (RBS)-60000
- K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
- K000397 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
- K981669 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
- K974018 — WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
- K963166 — O'REGAN LIGATOR
- K964079 — SPEEDBAND MULTIPLE BAND LIGATOR
- K960020 — SOLO BAND LIGATOR
- K952262 — SPEEDBAND
- K882297 — 1/2 CM REAR TIP EXTENDER (RTE)
- K880648 — ENDOSCOPIC ELASTIC BAND LIGATOR
- K832192 — SUCTION-HEMORRHOID-LIGATOR
- K801352 — HEMORRHOIDAL LIGATION INSTR. SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.