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510(k) K210116

Video Endoscopy System, 3D Video Endoscopy System by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2021
Date Received
January 19, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laparoscope, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.1720
Review Panel
OB
Submission Type

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  • K183153 — Microwave Ablation System (July 8, 2019)
  • K190052 — Radio Frequency Ablation System (June 25, 2019)

Other clearances for product code HET

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  • K243821 — i-Cut (April 25, 2025)
  • K221642 — SIRIUS Endoscope System (December 12, 2022)
  • K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (September 17, 2021)
  • K210104 — SurroundScope System (July 8, 2021)
  • K201617 — TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera (March 12, 2021)
  • K200216 — 4K UHD Camera System (August 21, 2020)
  • K200638 — LAP-iX Suction Irrigation (April 3, 2020)
  • K190190 — WV1 Endoscope (November 1, 2019)
  • K190744 — ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) (August 29, 2019)