# K101218: Patchassist

- Pathway: 510(k) (Traditional)
- Applicant: Polytouch Medical, Ltd.
- Decided: Jun 17, 2010 after 48 days
- Product code: ORQ (Mesh, Surgical, Deployer)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K103269: Patchassist Large (2010), 3 descendants of its own
- K121139: Accumesh Deployment System (2012), 2 descendants of its own
- K123066: Accumesh Deployment System (2012), 1 descendant of its own
- K130782: Accumesh Deployment System (2013), 0 descendants of its own

## Indications for use
The PatchAssist device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

Source page: https://510kreport.com/device/K101218
Methodology: https://510kreport.com/methodology
