# K973313: Innovasive Devices Y-Knot Suture Clip

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Dec 1, 1997 after 89 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
66 later devices descend from it; 2 cite it directly.
0 of 67 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) Ethibond Extra polyester suture: named in the summary without a submission number

## Most influential descendants
- K051609: Quill Synthetic Absorbable Barbed Suture (2005), 64 descendants of its own
- K071989: Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material (2007), 31 descendants of its own
- K080680: Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone (2008), 30 descendants of its own
- K080985: Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) (2008), 29 descendants of its own
- K072028: Quill Self-Retaining System (SRS) Comprised of Monoderm (2007), 26 descendants of its own

## Indications for use
The Intended Use for the Innovasive Y-Knot Suture Clip is for use in general soft tissue approximation and /or ligation with #1 and #2 braided polyester suture.

Source page: https://510kreport.com/device/K973313
Methodology: https://510kreport.com/methodology