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510(k) K210104

SurroundScope System by 270surgical , Ltd. — Product Code HET

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2021
Date Received
January 14, 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

Other clearances by 270surgical , Ltd.

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  • K210116 — Video Endoscopy System, 3D Video Endoscopy System (October 13, 2021)
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  • 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)