# K111006: CI-Snap Wound Care System

- Pathway: 510(k) (Traditional)
- Applicant: Spiracur, Inc.
- Decided: Jul 21, 2011 after 101 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: 1 generation back to DEN080011 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- DEN080011: Snap Wound Care Device, Spiracur, Inc. (2009). Our reading of the summary gave K081406, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080011, Snap Wound Care Device (Spiracur, Inc.), granted Aug 7, 2009; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K133137: Cisnap Closed Incision System (2014), 0 descendants of its own

## Indications for use
The Cl-SNaPTM Wound Care System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of small amounts of exudates from surgical incisions that continue to drain following sutured or stapled closure.

Source page: https://510kreport.com/device/K111006
Methodology: https://510kreport.com/methodology