# K090159: Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families

- Pathway: 510(k) (Special)
- Applicant: Incisive Surgical, Inc.
- Decided: Feb 6, 2009 after 15 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K081018: Syngo Dynamics Version 7.0, Siemens Medical Solutions (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K131563: Subq IT! Bioabsorbable Skin Closure System (2014), 0 descendants of its own
- K132669: Proxifast Absorbable Staple (2014), 0 descendants of its own

## Recalls of this device
- Mar 19, 2015 · Class II · Z-1545-2015: A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.

## Indications for use
Synthetic absorbable INSORB TM staples are intended for use in 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. Stapler is designed to aid in the prevention of accidental needle stick injuries.

Source page: https://510kreport.com/device/K090159
Methodology: https://510kreport.com/methodology