# K110402: Biodesign Nipple Reconstruction Cylinder

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Jun 20, 2011 after 129 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: 5 generations back to K921895 (1992). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K062696: Surgisis, Surgisis ES, Cook Biotech, Inc. (2006) Summary page 1.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 1.
- K050246: Sis Dermal Augmentation Strand, Cook Biotech, Inc. (2005) Summary page 1.
- K070738: Sis Facial Cylinder, Sis Facial Implant, Cook Biotech, Inc. (2007) Summary page 1.

## Indications for use
The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K110402
Methodology: https://510kreport.com/methodology