Home / 510(k) Clearances / K001236

510(k) K001236

RIZA BAND STRETCHER (RBS)-60000 by R-Med, Inc. — Product Code FHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2000
Date Received
April 18, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ligator, Hemorrhoidal
Device Class
Class II
Regulation Number
876.4400
Review Panel
GU
Submission Type

Other clearances by R-Med, Inc.

  • K953360 — R-MED ABDOMINAL WALL ELEVATOR (January 11, 1996)
  • K954882 — RIZA-RIBE NEEDLE (MODIFICATION) (November 16, 1995)
  • K953441 — RIZA-RIBE NEEDLE (August 18, 1995)
  • K950108 — R-MED MINI-RETRACTOR (May 11, 1995)
  • K942411 — R-MED DISPOSABLE PLUG (March 31, 1995)
  • K945637 — R-MED MOTORIZED LAPAROSCOPIC HANDLE (December 7, 1994)
  • K943818 — MANUAL LAPAROSOPIC HANDLE, INTERCHANGEABLE LAPAROSCOPIC TOOL UNITS (August 29, 1994)
  • K935031 — RIZA-RIBE NEEDLE (April 25, 1994)

Other clearances for product code FHN

  • K213223 — Multi-Band Ligator (June 6, 2022)
  • K172985 — Ligation Device (June 14, 2018)
  • K150718 — Wi-3 HAL-RAR System (June 12, 2015)
  • K131282 — NEXUS HEMORRHOID LIGATOR (July 11, 2013)
  • K093497 — THD BANDY (July 15, 2010)
  • K091519 — HAEMOBAND MULTI-LIGATOR (July 28, 2009)
  • K070881 — LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (September 26, 2007)
  • K020824 — SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 (April 12, 2002)
  • K020526 — MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR (March 19, 2002)
  • K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNE (April 24, 2000)