INTUITIVE SURGICAL BIPOLAR FORCEPS— 510(k) K012833
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K012833 for INTUITIVE SURGICAL BIPOLAR FORCEPS, Substantially Equivalent on 2001-11-16. 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
- Mountain View, 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 K012833
K-number listed on FDA's recall record- Z-1431-2013 — 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
- Z-1432-2013 — 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
- Z-1433-2013 — 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012833.
Data sourced from openFDA. This site is unofficial and independent of the FDA.