# K133137: Cisnap Closed Incision System

- Pathway: 510(k) (Traditional)
- Applicant: Spiracur, Inc.
- Decided: Feb 25, 2014 after 137 days
- Product code: OKO (Negative Pressure Wound Therapy Non-Powered Suction Apparatus)
- Device class: 2
- Regulation: 21 CFR 878.4683
- 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 K914579 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111006: CI-Snap Wound Care System, Spiracur, Inc. (2011) Summary page 4.
- K100821: Prevena Incision Management System, Kci USA, Inc. (2010) Summary page 2.
- K981299: Silverlon Contact Wound Dressing, Argentum International, LLC (1998) Summary page 2.
- K040518: Select Fabricators, Inc., Agmed Tex Wound Dressing, Select Fabricators, Inc. (2004) Summary page 2.

## Indications for use
The ciSNaP® Closed Incision System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudate from surgical incisions that continue to drain following sutured or stapled closure.

Source page: https://510kreport.com/device/K133137
Methodology: https://510kreport.com/methodology