# Polyganics B.V.,

- Location (FDA's records): Groningen, NL
- FDA decisions: 9 (2003–2014): 9 510(k) clearances
- Product codes: LYA (3), JXI (3), FTL (1), NHB (1), KCN (1)
- Predicates its devices cite: 18 (6 its own); citations of its devices by later devices: 20 (6 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Invotec International, Inc.: 2 (https://510kreport.com/company/invotec-international)
- Integra LifeSciences Corporation: 2 (https://510kreport.com/company/integra-lifesciences)
- Macropore Biosurgery, Inc.: 1 (https://510kreport.com/company/macropore-biosurgery)
- Osteobiologics, Inc.: 1 (https://510kreport.com/company/osteobiologics)
- Genzyme Corp.: 1 (https://510kreport.com/company/genzyme)
- Xomed, Inc.: 1 (https://510kreport.com/company/xomed)
- Medtronic Xomed, Inc.: 1 (https://510kreport.com/company/medtronic-xomed)
- Hemostasis, LLC: 1 (https://510kreport.com/company/hemostasis)

## Firms that cite its devices most
- Celestray Biotech Company, LLC.,: 2 (https://510kreport.com/company/celestray-biotech)
- Polyganics Innovations BV: 2 (https://510kreport.com/company/polyganics-innovations)
- Arthrocare Corp.: 1 (https://510kreport.com/company/arthrocare)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)
- Cogent Therapeutics, LLC: 1 (https://510kreport.com/company/cogent-therapeutics)
- Hemostasis, LLC: 1 (https://510kreport.com/company/hemostasis)
- Medtronic Xomed, Inc.: 1 (https://510kreport.com/company/medtronic-xomed)
- KLISBio S.r.l.: 1 (https://510kreport.com/company/klisbio)

## Its most-cited devices
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ (2005), cited by 10
- K112267: Neurolac (R) Nerve Guide (2011), cited by 3
- K042811: Vivosorb Sheet, Model FS01 (2004), cited by 2
- K050573: Neurolac Nerve Guide (2005), cited by 2
- K032115: Neurolac Nerve Guide Models NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 (2003), cited by 2
- K070715: Nasopore Ear (2007), cited by 1

## Recent decisions
- K141816: Hemopore (Oct 23, 2014)
- K141423: Nasopore-FD (Aug 7, 2014)
- K112267: Neurolac (R) Nerve Guide (Oct 20, 2011)
- K070715: Nasopore Ear (May 7, 2007)
- K062540: Nasopore Ear, Models  ND04, ND05 (Oct 18, 2006)
- K052099: Nasopore Nasal Dressing, Model Ndox-Yyy/ZZ (Nov 21, 2005)
- K050573: Neurolac Nerve Guide (May 4, 2005)
- K042811: Vivosorb Sheet, Model FS01 (Nov 8, 2004)

Source page: https://510kreport.com/company/polyganics