# Macropore Biosurgery, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 17 (2000–2004): 17 510(k) clearances
- Product codes: JEY (3), HRS (2), KWQ (2), FTL (2), QPB (1), MTZ (1), JDI (1), NHB (1), GXR (1), OMH (1), EZX (1), MQN (1)
- Predicates its devices cite: 17 (4 its own); citations of its devices by later devices: 46 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Byron Medical: 1 (https://510kreport.com/company/byron-medical)
- Sound Surgical Technologies, LLC: 1 (https://510kreport.com/company/sound-surgical-technologies)
- Sofamor Danek USA,Inc.: 1 (https://510kreport.com/company/sofamor-danek-usa)
- Medtronic Sofamor Danek USA, Inc.: 1 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Medtronic Sofamor Danek: 1 (https://510kreport.com/company/medtronic-sofamor-danek)
- Bio-Vascular, Inc.: 1 (https://510kreport.com/company/bio-vascular)
- Sulzer Carbomedics, Inc.: 1 (https://510kreport.com/company/sulzer-carbomedics)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)

## Firms that cite its devices most
- Inion, Ltd.: 6 (https://510kreport.com/company/inion)
- Mast Biosurgery USA, Inc.: 4 (https://510kreport.com/company/mast-biosurgery-usa)
- Tepha, Inc.: 2 (https://510kreport.com/company/tepha)
- Cytori Therapeutics, Inc.: 2 (https://510kreport.com/company/cytori-therapeutics)
- Ebi, L.P.: 2 (https://510kreport.com/company/ebi)
- Kensey Nash Corp.: 2 (https://510kreport.com/company/kensey-nash)
- ETHICON, Inc.: 1 (https://510kreport.com/company/ethicon)
- Medi-Khan USA, Inc.: 1 (https://510kreport.com/company/medi-khan-usa)

## Its most-cited devices
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet (2003), cited by 9
- K010911: Macropore OS Spinal System (2001), cited by 8
- K994158: Macrosorbos Protective Sheet (2000), cited by 5
- K012025: Macropore Surgiwrap (TS) (2001), cited by 5
- K042261: Macropore Puricel Lipoplasty System (2004), cited by 3
- K041105: Macropore Hydrosorb Spine System (2004), cited by 3

## Recent decisions
- K042261: Macropore Puricel Lipoplasty System (Sep 20, 2004)
- K041105: Macropore Hydrosorb Spine System (Jul 28, 2004)
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet (Sep 22, 2003)
- K031785: Macropore Cardio-Wrap (TS) (Sep 4, 2003)
- K024169: Macropore OS Reconstruction (Jul 1, 2003)
- K023643: Macropore Surgical Barrier Film (Feb 21, 2003)
- K021164: Macropore OS Trauma (Jul 1, 2002)
- K012025: Macropore Surgiwrap (TS) (Dec 3, 2001)

Source page: https://510kreport.com/company/macropore-biosurgery