MINT— 510(k) K130191

Clearance details

Applicant

Hans Biomed Corporation

Product code

Code NEW

Device class

Class 2

Regulation

21 CFR 878.4840

Advisory panel

General, Plastic Surgery

Date received

2013-01-25

Decision date

2013-06-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Brea, CA, US

• K253879 — MONOFIX PDO2026-08-25
• K261988 — Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture2026-07-09
• K252171 — Barbed PDO Suture2026-06-12
• K252047 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices2026-05-18
• K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture2025-11-12

• K220549 — MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 10142023-03-07
• K192423 — MINT Product Family2020-09-09
• K171568 — SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty2018-02-22

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 →