# K161737: RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed

- Pathway: 510(k) (Abbreviated)
- Applicant: Myco Medical
- Decided: Mar 2, 2017 after 252 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: 2 generations back to K042285 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081001: PD Synth, Absorbable (Poly Dioxanone) Suture, Sutures India Pvt., Ltd. (2008) Summary page 4.

## Indications for use
The REDIDIOX Suture is used in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

Source page: https://510kreport.com/device/K161737
Methodology: https://510kreport.com/methodology