Home / 510(k) Clearances / K212999

510(k) K212999

Multi-Functional Electrosurgical Knife by Anrei Medical (Hangzhou) Co., Ltd. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2022
Date Received
September 20, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Anrei Medical (Hangzhou) Co., Ltd.

  • K210917 — Single Use Injection Needle (May 28, 2021)
  • K202987 — Rescue Pulmonary Grasping Forceps (April 29, 2021)
  • K210660 — Stone Retrieval Balloon Catheter (April 27, 2021)
  • K201771 — Single Use Rotatable and Repositionable Hemoclip (October 19, 2020)
  • K192048 — Single Use Endoscope Valves Set (May 14, 2020)

Other clearances for product code KNS

  • K252388 — Vanquish Water Vapor Ablation Device (November 26, 2025)
  • K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (November 25, 2025)
  • K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si (October 17, 2025)
  • K250351 — Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical (October 10, 2025)
  • K251104 — SureTome™ SW Sphincterotome with DomeTip (September 29, 2025)
  • K251226 — Aqua Medical RF Vapor Ablation System (August 8, 2025)
  • K250584 — Rezum System (June 11, 2025)
  • K242774 — SpydrBlade Flex Instrument (PRD-RG1-001) (June 6, 2025)
  • K241855 — SB Knife Jr2 (MD-47702 and MD-47702L) (March 26, 2025)
  • K242192 — Disposable Sphincterotome (February 6, 2025)