# K120373: Insorb Absorbalbe Staple

- Pathway: 510(k) (Special)
- Applicant: Incisive Surgical, Inc.
- Decided: Mar 16, 2012 after 39 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K090159: Insorb Absorbable Staple, Model 1020, 1025, and Other Product Families, Incisive Surgical, Inc. (2009). 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

## Recalls of this device
- Aug 29, 2018 · Class II · Z-0078-2019: Possible compromise of the sterile barrier integrity
- 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 staples are intended for the subcuticular closure of skin where an absorbable tissue fastener is desired for temporary tissue approximation.

Source page: https://510kreport.com/device/K120373
Methodology: https://510kreport.com/methodology