DeviceClearance

ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT— 510(k) K031538

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K031538 for ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT, Substantially Equivalent on 2003-06-27. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant
Boston Scientific Corp
Product code
Code KNT
Device class
Class 2
Regulation
21 CFR 876.5980
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Natick,, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KNT

product code KNT
Death
192
Injury
6,034
Malfunction
4,049
Other
1
Total
10,276

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 K031538

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 K031538.

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