DeviceClearance

Ion Endoluminal System; Flexision Biopsy Needle— 510(k) K182188

Substantially Equivalent

Intuitive Surgical

FDA 510(k) clearance K182188 for Ion Endoluminal System; Flexision Biopsy Needle, Substantially Equivalent on 2019-02-14. Applicant: Intuitive Surgical. Device class: 2.

Clearance details

Device name as filed
Ion Endoluminal System ; Flexision Biopsy Needle
Applicant
Intuitive Surgical
Product code
Code EOQ
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sunnyvale, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

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 K182188

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 K182188.

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