DeviceClearance

LAURIMED POLYPVAC MICRODEBRIDER— 510(k) K133133

Substantially Equivalent

Laurimed, LLC

FDA 510(k) clearance K133133 for LAURIMED POLYPVAC MICRODEBRIDER, Substantially Equivalent on 2013-12-23. Applicant: Laurimed, LLC. Device class: 2.

Clearance details

Applicant
Laurimed, LLC
Product code
Code ERL
Device class
Class 2
Regulation
21 CFR 874.4250
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Ramon, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ERL

product code ERL
Malfunction
11,234
Total
11,234

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 K133133

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 K133133.

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