DeviceClearance

HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS— 510(k) K132658

Substantially Equivalent

Teleflex Medical

FDA 510(k) clearance K132658 for HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS, Substantially Equivalent on 2013-11-27. Applicant: Teleflex Medical. Device class: 2.

Clearance details

Applicant
Teleflex Medical
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
Traditional
Location
Durham, NC, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FZP

view all

More clearances from Teleflex Medical

view all

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 K132658

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 K132658.

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