# K022666: Pdo (Polydioxanone) Monofilament Synthetic Absorbable Suture U.S.P.

- Pathway: 510(k) (Traditional)
- Applicant: Arc Medical Supplies (Beijing) Co, Ltd.
- Decided: Oct 9, 2002 after 61 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MONO-DOX synthetic absorbable polydioxanone surgical sutures: named in the summary without a submission number

## Indications for use
PDO (Polydioxanone) Monofilament Synthetic Absorbable Sutures U.S.P. are indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDO is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.

Source page: https://510kreport.com/device/K022666
Methodology: https://510kreport.com/methodology