K252644

Substantially Equivalent

PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture

Applicant: M/s. Meril Endo Surgery Private Limited.
Product code: NEW
Advisory panel: General, Plastic Surgery
Date received: 2025-08-21
Decision date: 2025-09-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Vapi, IN

Download summary PDF View on FDA.gov ↗

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.