DeviceClearance

ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS— 510(k) K133700

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K133700 for ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS, Substantially Equivalent on 2014-05-14. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant
Boston Scientific Corporation
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
Marlboro, MA, 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 K133700

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 K133700.

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