PROBE HOLDER SYSTEM— 510(k) K071405
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K071405 for PROBE HOLDER SYSTEM, Substantially Equivalent on 2007-10-09. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Product code LKF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code LKF
view allMore clearances from Intuitive Surgical, Inc.
view all- K263592 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- K262455 — da Vinci 5 Handheld Camera Head (470080) +4 more
- K261823 — da Vinci Surgical System, Model IS5000
- K253702 — Intuitive Endoluminal Gastrointestinal System (IG1000)
- K261824 — da Vinci Surgical System, Model IS5000
Adverse events under product code LKF
product code LKF- Malfunction
- 643
- Other
- 2
- Total
- 645
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.