da Vinci Single-Site Instrument and Accessories— 510(k) K152448
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K152448 for da Vinci Single-Site Instrument and Accessories, Substantially Equivalent on 2016-03-09. Applicant: Intuitive Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- Intuitive Surgical, Inc.
- Product code
- Code NAY
- 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 NAY
view allMore clearances from Intuitive Surgical, Inc.
view allAdverse events under product code NAY
product code NAY- Death
- 433
- Injury
- 7,927
- Malfunction
- 93,790
- Other
- 19
- Total
- 102,169
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 K152448
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 K152448.
Data sourced from openFDA. This site is unofficial and independent of the FDA.