FDA Inspection
Intuitive Surgical, Inc.Intuitive Surgical, Inc. – FDA Inspection, May 30, 2013
Record Details
This FDA Inspection record concerns Intuitive Surgical, Inc., with an inspection on May 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Intuitive Surgical, Inc.
- Inspection Date
- May 30, 2013
- Product Type
- Devices
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ID · dcdbb3f4-fcf7-465c-b193-c6f00fe041b5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 832849
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 806.10(c)(8)Illness report
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Intuitive Surgical, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2025 | OAI | San Francisco District Office | Compliance: Medical Devices |
| December 21, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 14, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 27, 2021 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 26, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Intuitive Surgical, Inc.
- FDA Inspection 1276877 - 2025-11-05
- FDA Inspection 1227392 - 2023-12-21
- FDA Inspection 1225346 - 2023-12-14
- FDA Inspection 1149960 - 2021-08-27
- FDA Inspection 1020267 - 2017-04-26
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