FDA Product Code FHN: Ligator, Hemorrhoidal
Leading manufacturers include Boston Scientific Corp, Leo Medical Co., Ltd. and Beijing Zksk Technology Co., Ltd..
22
Total
22
Cleared
116d
Avg days
1980
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Ligator, Hemorrhoidal Devices (Product Code FHN)
22 devices
Cleared
Jun 06, 2022
Multi-Band Ligator
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology
250d
Cleared
Jun 14, 2018
Ligation Device
Leo Medical Co., Ltd.
Gastroenterology & Urology
260d
Cleared
Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
Boston Scientific Corp
Gastroenterology & Urology
29d
Cleared
Mar 07, 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
Boston Scientific Corp
Gastroenterology & Urology
29d
Cleared
Jun 04, 1998
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
Boston Scientific Corp
Gastroenterology & Urology
23d
Cleared
Feb 13, 1997
SPEEDBAND MULTIPLE BAND LIGATOR
Boston Scientific Corp
Gastroenterology & Urology
125d
Cleared
Feb 29, 1996
SPEEDBAND
Boston Scientific Corp
Gastroenterology & Urology
290d
Cleared
Jul 08, 1980
HEMORRHOIDAL LIGATION INSTR. SYSTEM
Depuy, Inc.
Gastroenterology & Urology
29d
About Product Code FHN - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code FHN since 1980, with 22 receiving FDA clearance (average review time: 116 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.