# K023710: Visorb Swift

- Pathway: 510(k) (Traditional)
- Applicant: Cp Medical
- Decided: Jan 17, 2003 after 74 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices 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) Predicate devices marketed by Ethicon: named in the summary without a submission number
- (no number) Predicate devices marketed by B/Braun: named in the summary without a submission number

## Most influential descendants
- K100461: PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut (2010), 5 descendants of its own
- K130737: Synthetic Absorbable Suture (2014), 2 descendants of its own
- K142810: WEGO-PGCL Absorbable Surgical Monofilament Suture (2014), 1 descendant of its own
- K130083: Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture (2013), 1 descendant of its own
- K232372: Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (2024), 0 descendants of its own

## Indications for use
General soft tissue approximation; including use in Ophthalmic surgery, but not for use in Cardiovascular and Neurological tissue approximation.

Source page: https://510kreport.com/device/K023710
Methodology: https://510kreport.com/methodology