MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE— 510(k) K031216

Name: FDA 510(k) clearance K031216
Creator: U.S. Food and Drug Administration
Published: 2003-07-17

Substantially Equivalent

Aesculap

FDA 510(k) clearance K031216 for MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE, Substantially Equivalent on 2003-07-17. Applicant: Aesculap. Device class: 2.

Clearance details

Applicant: Aesculap
Product code: Product code NEW
Device class: Class 2
Regulation: 21 CFR 878.4840
Advisory panel: General, Plastic Surgery
Date received: 2003-04-17
Decision date: 2003-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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K252171 — Barbed PDO Suture2026-06-12
K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18

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K062510 — AESCULAP STERILCONTAINER SYSTEM2006-11-17
K061135 — MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME0192006-07-11
K043079 — BICONTACT HIP SYSTEM WITH U-CAP2004-12-08

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.