ENDOWRIST ONE VESSEL SEALER— 510(k) K110639
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K110639 for ENDOWRIST ONE VESSEL SEALER, Substantially Equivalent on 2011-12-28. 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 K110639
K-number listed on FDA's recall record- Z-1141-2015 — EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05
- Z-1689-2013 — da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110639.
Data sourced from openFDA. This site is unofficial and independent of the FDA.