MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture— 510(k) K172659

Clearance details

Applicant

M/s. Meril Endo Surgery Private Limited.

Product code

Code GAM

Device class

Class 2

Regulation

21 CFR 878.4493

Advisory panel

General, Plastic Surgery

Date received

2017-09-05

Decision date

2017-09-28

Decision

Substantially Equivalent

Clearance type

Special

Location

Chala, Vapi, IN

• K253394 — Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture2026-06-25
• K253530 — Trexon Monofilament Synthetic Absorbable Suture2026-05-28
• K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture2026-02-06
• K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device2025-12-22
• K253620 — TroClose 12002025-12-16

• K252644 — PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more2025-09-23
• K233386 — Monik - Disposable Endoscopic Trocar2024-05-24
• K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture +1 more2024-04-25
• K230981 — Meriglu Topical Skin Adhesive2024-03-16
• K200452 — Meril-Bonewax2023-03-27

Death

45

Injury

5,711

Malfunction

30,744

Other

4

Total

36,504

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 →