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510(k) K960020

SOLO BAND LIGATOR by Surcraft, LLC — Product Code FHN

K960020 is an FDA 510(k) premarket notification submitted by Surcraft, LLC for the device "SOLO BAND LIGATOR". The FDA issued a decision of Substantially Equivalent on April 1, 1996. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1996
Date Received
January 2, 1996
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 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)
  • K001236 — RIZA BAND STRETCHER (RBS)-60000 (July 17, 2000)

FDA data resources