DeviceClearance

Weck Auto Endo5 Hem-o-lok Ligating Clip Applier— 510(k) K152081

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K152081 for Weck Auto Endo5 Hem-o-lok Ligating Clip Applier, Substantially Equivalent on 2015-08-26. Applicant: Teleflexmedical, Inc.. Device class: 2.

Clearance details

Applicant
Teleflexmedical, Inc.
Product code
Code FZP
Device class
Class 2
Regulation
21 CFR 878.4300
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Morrisville, NC, US
Download summary PDFView on FDA.gov ↗

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More clearances from Teleflexmedical, Inc.

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Adverse events under product code FZP

product code FZP
Death
11
Injury
726
Malfunction
10,830
Other
1
Total
11,568

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 K152081

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 K152081.

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