# K033985: Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10

- Pathway: 510(k) (Traditional)
- Applicant: Pm Devices, Inc.
- Decided: Jun 4, 2004 after 164 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: 3 generations back to K842066 (1985). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031948: Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16, Pm Devices, Inc. (2003) Summary page 1.
- K963967: Glycar Pericardial Patch, Glycar, Inc. (1997) Summary page 1.
- K983162: Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips, Peri-Strips Dry, Vasc, Bio-Vascular, Inc. (1998) Summary page 1.
- K942010: Vascu-Guard, Bio-Vascular, Inc. (1994) Summary page 1.
- K921895: Tissue Patch, Tissue Graft, Bio-Vascular, Inc. (1992) Summary page 1.

## Most influential descendants
- K063556: Peripatch Endo-Sleeve (2007), 0 descendants of its own

## Indications for use
The PeriPatch TM Sleeve is intended for use as a surgical patch mesh material to reinforce surgical staples during stapling procedures and for reinforcing suture lines for cardiovascular and general procedures. Stapling is carried out according to the stapler manufacture's instructions. The sleeves are intended for staple reinforcement during a number of resection techniques such as lung volume reductions, biopsies, lobectomies, gastric banding, rectal and vaginal prolapse, and urethral sling.

Source page: https://510kreport.com/device/K033985
Methodology: https://510kreport.com/methodology