# Integra Lifesciences Production Corporation

- Location (FDA's records): Mansfield, MA
- FDA decisions: 9 (2021–2026): 9 510(k) clearances
- Product codes: JXG (7), GWM (2)
- 510(k) review time since 2016: median 103 days, against 134 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 6 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Codman & Shurtleff, Inc.: 6 (https://510kreport.com/company/codman-shurtleff)
- Integra LifeSciences Corporation: 2 (https://510kreport.com/company/integra-lifesciences)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)

## Its most-cited devices
- K210993: CereLink ICP Monitor (2021), cited by 1
- K233445: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (2024), cited by 1
- K233448: Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (2023), cited by 1

## Recent decisions
- K261004: Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684) (Jun 23, 2026)
- K243531: Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (Aug 8, 2025)
- K243552: Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762) (Aug 6, 2025)
- K232890: CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) (Feb 4, 2024)
- K233445: Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter (Jan 17, 2024)
- K233448: Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set (Dec 19, 2023)
- K223330: Certas Plus Programmable Valves (Feb 1, 2023)
- K221840: Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves (Oct 14, 2022)

Source page: https://510kreport.com/company/integra-lifesciences-production