DeviceClearance

da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments— 510(k) K214095

Substantially Equivalent

Intuitive Surgical, Inc.

FDA 510(k) clearance K214095 for da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments, Substantially Equivalent on 2022-08-15. 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 K214095

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 K214095.

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