# K061784: Insorb Absorbable Staple, Model 1020

- Pathway: 510(k) (Special)
- Applicant: Incisive Surgical, Inc.
- Decided: Jul 26, 2006 after 30 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
Longest line of descent: 3 generations back to K915489 (1992). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033602: Insorb Absorbable Staple, Model SP-B20, Incisive Surgical, Inc. (2003) Summary page 1.

## Most influential descendants
- K131563: Subq IT! Bioabsorbable Skin Closure System (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 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.

Source page: https://510kreport.com/device/K061784
Methodology: https://510kreport.com/methodology