DeviceClearance

Surgical Gut Suture— 510(k) K142656

Substantially Equivalent

Covidien

FDA 510(k) clearance K142656 for Surgical Gut Suture, Substantially Equivalent on 2015-01-29. Applicant: Covidien. Device class: 2.

Clearance details

Applicant
Covidien
Product code
Code GAL
Device class
Class 2
Regulation
21 CFR 878.4830
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
North Haven, CT, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GAL

product code GAL
Malfunction
681
Other
1
Total
682

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 K142656

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 K142656.

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