DeviceClearance

PENTAX Video Colonoscopes (EC Family)— 510(k) K181084

Substantially Equivalent

Pentax of America, Inc.

FDA 510(k) clearance K181084 for PENTAX Video Colonoscopes (EC Family), Substantially Equivalent on 2019-01-18. Applicant: Pentax of America, Inc.. Device class: 2.

Clearance details

Applicant
Pentax of America, Inc.
Product code
Code FDF
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montvale, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FDF

product code FDF
Death
8
Injury
729
Malfunction
61,773
Total
62,510

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 K181084

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 K181084.

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