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510(k) K192877

Senhance Surgical System by Transenterix, Inc. — Product Code NAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2019
Date Received
October 8, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Surgical, Computer Controlled Instrument
Device Class
Class II
Regulation Number
876.1500
Review Panel
SU
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Transenterix, Inc.

  • K202166 — Senhance Surgical System (March 2, 2021)
  • K200049 — Senhance Surgical System (March 9, 2020)
  • K191482 — Senhance Surgical System (July 11, 2019)
  • K182421 — Senhance Ultrasonic System (January 11, 2019)
  • K183098 — Senhance Surgical System (December 6, 2018)
  • K181517 — Senhance Surgical System (October 9, 2018)
  • K180163 — TransEnterix Senhance Surgical System (May 25, 2018)
  • K171120 — Senhance Surgical Robotic System (October 13, 2017)
  • K122299 — SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER S (October 25, 2012)
  • K120403 — SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER (April 16, 2012)

Other clearances for product code NAY

  • K253986 — da Vinci Force Feedback Instruments (March 11, 2026)
  • K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (January 16, 2026)
  • K251739 — da Vinci Surgical System (IS5000) (January 16, 2026)
  • K252675 — da Vinci SP Surgical System (SP1098) (December 15, 2025)
  • K252069 — da Vinci SP Surgical System (SP1098) (December 2, 2025)
  • K251426 — da Vinci SP Surgical System (SP1098) (October 3, 2025)
  • K251817 — da Vinci SP Surgical System (SP1098) (September 10, 2025)
  • K251227 — da Vinci Surgical System (IS5000) (September 8, 2025)
  • K251324 — da Vinci SP Surgical System (SP1098) (August 29, 2025)
  • K252350 — da Vinci SP Firefly Imaging System (August 28, 2025)