DeviceClearance

PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL— 510(k) K231249

Substantially Equivalent

Pentax of America, Inc.

FDA 510(k) clearance K231249 for PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL, Substantially Equivalent on 2023-07-28. Applicant: Pentax of America, Inc.. Device class: 2.

Clearance details

Applicant
Pentax of America, Inc.
Product code
Code PEA
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 PEA

product code PEA
Malfunction
515
Total
515

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 K231249

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 K231249.

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