# K030786: Mono-Swift

- Pathway: 510(k) (Abbreviated)
- Applicant: Cp Medical
- Decided: May 6, 2003 after 55 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 1 (0 Class I)
- 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) CP Medical’s polydioxanone surgical suture: named in the summary without a submission number

## Recalls of this device
- Apr 23, 2014 · Class II · Z-1708-2014: CP Medical, Inc., is recalling one lot of Monoswift PGCL [poly (glycolide-co-caprolactone)] Absorbable Sutures for failing to meet the USP minimum average value for knot pull (tensile) strength.

## Indications for use
CP Medical’s synthetic absorbable monofilament is indicated for use in soft tissue approximation and/or ligation but not for use in cardiovascular or neurological surgery, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K030786
Methodology: https://510kreport.com/methodology