INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180— 510(k) K050005
Substantially EquivalentIntuitive Surgical, Inc.
FDA 510(k) clearance K050005 for INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180, Substantially Equivalent on 2005-01-25. 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
- Special
- 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 K050005
K-number listed on FDA's recall record- Z-1442-2013 — 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
- Z-1425-2013 — Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050005.
Data sourced from openFDA. This site is unofficial and independent of the FDA.