PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE— 510(k) K081001

Name: FDA 510(k) clearance K081001
Creator: U.S. Food and Drug Administration
Published: 2008-06-09

Substantially Equivalent

Sutures India Pvt., Ltd.

FDA 510(k) clearance K081001 for PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE, Substantially Equivalent on 2008-06-09. Applicant: Sutures India Pvt., Ltd.. Device class: 2.

Clearance details

Applicant: Sutures India Pvt., Ltd.
Product code: Product code NEW
Device class: Class 2
Regulation: 21 CFR 878.4840
Advisory panel: General, Plastic Surgery
Date received: 2008-04-08
Decision date: 2008-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangalore, IN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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