PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more— 510(k) K252644
Substantially EquivalentM/s. Meril Endo Surgery Private Limited.
FDA 510(k) clearance K252644 for PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more, Substantially Equivalent on 2025-09-23. Applicant: M/s. Meril Endo Surgery Private Limited.. Device class: 2.
Clearance details
- Device name as filed
- 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
- Code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Vapi, IN
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More clearances from M/s. Meril Endo Surgery Private Limited.
view all- K233386 — Monik - Disposable Endoscopic Trocar
- K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more
- K230981 — Meriglu Topical Skin Adhesive
- K200452 — Meril-Bonewax
- K200320 — Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
Adverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.