# K042261: Macropore Puricel Lipoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Macropore Biosurgery, Inc.
- Decided: Sep 20, 2004 after 28 days
- Product code: QPB (System, Suction, Lipoplasty For Removal)
- Device class: 2
- Regulation: 21 CFR 878.5040
- 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 K910696 (1991). 21 ancestors in all.
36 later devices descend from it; 3 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981172: Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles, Byron Medical (1998) Summary page 7.
- K022051: Soundvaser System, Sound Surgical Technologies, LLC (2002) Summary page 7.

## Most influential descendants
- K072587: Cytori Aft System (2007), 34 descendants of its own
- K092482: Tissu Trans Filtron, Models 3-TT-Filtron 2000-500 (2009), 17 descendants of its own
- K081848: Lipose Fat Transfer System (2008), 12 descendants of its own
- K120902: GID 700 (2012), 11 descendants of its own
- K100114: Fat Concentration System (2010), 8 descendants of its own

## Indications for use
The MacroPore Puricel Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: - Neurosurgery - Gastrointestinal and Affiliated Organ Surgery - Urological Surgery - Plastic and Reconstructive Surgery - General Surgery - Orthopedic Surgery - Gynecological Surgery - Thoracic Surgery - Laparoscopic Surgery The MacroPore Puricel Lipoplasty System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

Source page: https://510kreport.com/device/K042261
Methodology: https://510kreport.com/methodology