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None 470066

by Intuitive Surgical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

6 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886874120293 UDI-DI Date22 Mar 2024ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · 6 ongoing · FDA

    • Ongoing Z-2310-2026 FDA Class II initiated 24 Apr 2026

    Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

    • Ongoing Z-1355-2026 FDA Class II initiated 30 Dec 2025

    Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.

    • Ongoing Z-1428-2026 FDA Class II initiated 17 Nov 2025

    An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

    • Ongoing Z-1232-2026 FDA Class II initiated 7 Nov 2025

    Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction

    • Ongoing Z-1325-2025 FDA Class II initiated 26 Feb 2025

    Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

    • Ongoing Z-0964-2026 FDA Class II initiated 21 Aug 2024

    Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
None
Generic Name
Rigid optical laparoscope
Model / Reference
470066
Primary DI / UDI-DI
00886874120293
FDA Product Code
GCJ, NAY
GMDN Term
Rigid optical laparoscope
Device Class
Class II
Regulation Number
876.1500
GUDID distribution status
In Commercial Distribution
Sterilization Method
Hydrogen Peroxide
Size
Angle — 0 degree
Outer Diameter — 8 Millimeter

Related devices

Category: Rigid optical laparoscope

Cleared under the same submission (K232610)

Show all (12)

Other devices from Intuitive Surgical, Inc.

See all devices from Intuitive Surgical, Inc. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No