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510(k) K233113

ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) by Starmed Co., Ltd. — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2023
Date Received
September 27, 2023
Clearance Type
Special
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

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  • K203795 — Star RF Electrode, VIVA RF Electrode (April 1, 2021)
  • K181758 — ELRA Electrode (April 11, 2019)
  • K183538 — VIVA combo RF System (January 17, 2019)
  • K181249 — EUSRA RF Electrode (September 4, 2018)
  • K172012 — star RF Electrode, VIVA RF Electrode (March 14, 2018)
  • K163450 — VIVA combo RF System (March 8, 2017)

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