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510(k) K240852

da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) by Intuitive Surgical, Inc. — Product Code NAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2025
Date Received
March 28, 2024
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 Intuitive Surgical, Inc.

  • K253986 — da Vinci Force Feedback Instruments (March 11, 2026)
  • K253978 — Universal Seal (5-12 mm) (February 24, 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)
  • K251763 — IRISeg (December 16, 2025)
  • 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)
  • K252045 — Ion Endoluminal System (IF1000) (September 23, 2025)
  • K251817 — da Vinci SP Surgical System (SP1098) (September 10, 2025)

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)