da Vinci Handheld Camera— 510(k) K191043
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K191043 for da Vinci Handheld Camera, Substantially Equivalent on 2019-06-06. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code GCJ
view all- K262397 — CuratOR EX2742
- K260884 — UNIDRIVE Select System
- K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor
- K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)
- K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
More clearances from Intuitive Surgical, Inc.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K191043
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191043.
Data sourced from openFDA. This site is unofficial and independent of the FDA.