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System, Surgical, Computer Controlled Instrument

FDA product code NAY · Class 2 · Gastroenterology, Urology

586
Registered devices
143,877
Adverse events
248
Recalls
166
510(k) clearances

Devices with this code

EndoWrist;daVinci Si — INTUITIVE SURGICAL, INC.Senhance — Asensus Surgical, Inc.Force Feedback — INTUITIVE SURGICAL, INC.StitchKit — ORIGAMI SURGICAL LLCNone — INTUITIVE SURGICAL, INC.Senhance — Asensus Surgical, Inc.None — INTUITIVE SURGICAL, INC.StitchKit — ORIGAMI SURGICAL LLCEndoWrist — INTUITIVE SURGICAL, INC.EndoWrist;daVinci Si — INTUITIVE SURGICAL, INC.EndoWrist — INTUITIVE SURGICAL, INC.Senhance — Asensus Surgical, Inc.Single-Site — INTUITIVE SURGICAL, INC.None — INTUITIVE SURGICAL, INC.Sureform — INTUITIVE SURGICAL, INC.Senhance — Asensus Surgical, Inc.Force Feedback — INTUITIVE SURGICAL, INC.EndoWrist — INTUITIVE SURGICAL, INC.Senhance — Asensus Surgical, Inc.EndoWrist — INTUITIVE SURGICAL, INC.None — INTUITIVE SURGICAL, INC.STERILISATION TRAY — Aktormed GmbHSenhance — Asensus Surgical, Inc.None — INTUITIVE SURGICAL, INC.

Recent recalls

DateFirmReason
2026-04-24Intuitive Surgical, Inc.Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularl
2026-04-22Intuitive Surgical, Inc.Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would pr
2026-04-02Intuitive Surgical, Inc.Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.
2026-03-11Intuitive Surgical, Inc.Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
2025-12-30Intuitive Surgical, Inc.Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perc
2025-12-15Intuitive Surgical, Inc.Access Port System tray may develop cracks potentially resulting in a sterility breach.
2025-12-09Intuitive Surgical, Inc.Due to increased complaints for broken/frayed grip cables for reusable instruments.
2025-12-09Intuitive Surgical, Inc.Due to increased complaints for broken/frayed grip cables for reusable instruments.
2025-12-09Intuitive Surgical, Inc.Due to increased complaints for broken/frayed grip cables for reusable instruments.
2025-12-09Intuitive Surgical, Inc.Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.