DeviceClearance

PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family)— 510(k) K210485

Substantially Equivalent

Pentax of America, Inc.

FDA 510(k) clearance K210485 for PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family), Substantially Equivalent on 2021-05-13. Applicant: Pentax of America, Inc.. Device class: 2.

Clearance details

Applicant
Pentax of America, Inc.
Product code
Code FDS
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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More clearances from Pentax of America, Inc.

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Adverse events under product code FDS

product code FDS
Death
37
Injury
863
Malfunction
56,442
Other
1
Total
57,343

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 K210485

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 K210485.

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