# K251414: Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)

- Pathway: 510(k) (Traditional)
- Applicant: Feeltech Co., Ltd.
- Decided: Oct 20, 2025 after 166 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960653 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181582: DemeTECH DemeDIOX absorbable surgical suture, Demetech Corporation (2018) Summary page 5.
- K212380: PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture, ETHICON, Inc. (2022) Summary page 5.

## Indications for use
The Miracu™ Absorbable Polydioxanone Suture with Needle (MONO) is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location( s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

Source page: https://510kreport.com/device/K251414
Methodology: https://510kreport.com/methodology