# K131563: Subq IT! Bioabsorbable Skin Closure System

- Pathway: 510(k) (Traditional)
- Applicant: Opus Ksd, Inc.
- Decided: Apr 9, 2014 after 314 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K915489 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024117: Insorb Absorbable Staples, Model SP-B20, Incisive Surgical, Inc. (2003) Summary page 7.
- K033602: Insorb Absorbable Staple, Model SP-B20, Incisive Surgical, Inc. (2003) Summary page 7.
- K061784: Insorb Absorbable Staple, Model 1020, Incisive Surgical, Inc. (2006) Summary page 7.
- K090159: Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families, Incisive Surgical, Inc. (2009) Summary page 7.
- K120373: Insorb Absorbalbe Staple, Incisive Surgical, Inc. (2012) Summary page 7.

## Indications for use
The SubQ It!™ Bioabsorbable Skin Closure System is intended for use in humans for abdominal, thoracic, gynecologic, orthopedic, plastic and reconstructive surgery for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Source page: https://510kreport.com/device/K131563
Methodology: https://510kreport.com/methodology