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510(k) K211325

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2021
Date Received
April 30, 2021
Clearance Type
Traditional
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 Asensus Surgical, Inc.

  • K233866 — Senhance Surgical System (July 19, 2024)
  • K223095 — Senhance Surgical System (March 16, 2023)
  • K220889 — Senhance Surgical System (May 27, 2022)
  • K212054 — Senhance Surgical System (August 30, 2021)

Other clearances for product code NAY

  • K253986 — da Vinci Force Feedback Instruments (March 11, 2026)
  • K251739 — da Vinci Surgical System (IS5000) (January 16, 2026)
  • K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (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)