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510(k) K213223

Multi-Band Ligator by Beijing Zksk Technology Co., Ltd. — Product Code FHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2022
Date Received
September 29, 2021
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 Beijing Zksk Technology Co., Ltd.

  • K242192 — Disposable Sphincterotome (February 6, 2025)
  • K231721 — Disposable Hot Biopsy Forceps (December 14, 2023)
  • K213217 — Disposable hemoclip (November 14, 2022)
  • K213222 — Disposable Polypectomy Snare (June 6, 2022)
  • K213239 — Endoscopic Injection Needle (June 2, 2022)

Other clearances for product code FHN

  • 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)
  • K000297 — ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNE (April 24, 2000)