# K063556: Peripatch Endo-Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Pm Devices, Inc.
- Decided: Mar 20, 2007 after 113 days
- Product code: FTM (Mesh, Surgical)
- 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
Longest line of descent: 4 generations back to K842066 (1985). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033985: Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10, Pm Devices, Inc. (2004) Summary page 1.
- K992537: Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-Treated, Bio-Vascular, Inc. (2000) Summary page 1.

## Indications for use
The PeriPatch Aegis is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as: * Lung resections * Biopses • Lobectornies * Gastric banding • Abdominal and thoracic wall repair

Source page: https://510kreport.com/device/K063556
Methodology: https://510kreport.com/methodology