510(k) K241913
- Device
- da Vinci Handheld Camera
- Applicant
- Intuitive Surgical Operations, Inc.
- 510(k) number
- K241913
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-28
- Date received
- 2024-07-01
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Heena Khandelwal
- Address
- 1266 Kifer Rd. Sunnyvale CA US 94086 94086
FDA Registration Numbers
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Source Documents
Other 510(k) Records For Product Code GCJ
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| K250927 | KARL STORZ Cholangiography Set | Karl Storz SE & CO. KG | 2025-11-22 |
| K242606 | Nuvis® Wireless HD Camera System (Nuvis-2K) | Integrated Endoscopy, Inc. | 2025-11-20 |
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