DeviceClearance

OLYMPUS PBD STENTS— 510(k) K933200

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K933200 for OLYMPUS PBD STENTS, Substantially Equivalent on 1995-04-05. Applicant: Olympus Corp.. Device class: 2.

Clearance details

Applicant
Olympus Corp.
Product code
Code FGE
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Success, NY, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

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 K933200

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 K933200.

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