DeviceClearance

INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER— 510(k) K080291

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K080291 for INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER, Substantially Equivalent on 2008-03-19. 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
Download summary PDFView on FDA.gov ↗

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More clearances from Intuitive Surgical, Inc.

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Adverse 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 K080291

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080291.

Data sourced from openFDA. This site is unofficial and independent of the FDA.