# Codman & Shurtleff, Inc.

- Location (FDA's records): Raynham, MA
- FDA decisions: 152 (1976–2020): 152 510(k) clearances
- Product codes: JXG (23), GWM (9), DQY (8), HCG (7), HBF (6), GEI (5), HBL (5), GZJ (4), JDG (4), HCH (4), GWG (3), GCY (3)
- 510(k) review time since 2016: median 90 days, against 111 for FDA's reviews in the same codes and years (5 of 11 faster)
- Predicates its devices cite: 110 (44 its own); citations of its devices by later devices: 127 (44 its own)
- Recalls linked to its devices: 27 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Johnson & Johnson Professionals, Inc.: 27 (https://510kreport.com/company/johnson-johnson-professionals)
- Cordis Neurovascular, Inc.: 14 (https://510kreport.com/company/cordis-neurovascular)
- Micrus Endovascular Corporation: 9 (https://510kreport.com/company/micrus-endovascular)
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- DePuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/depuy-orthopaedics)
- Miltex, Inc.: 1 (https://510kreport.com/company/miltex)
- Genesis Medical Interventional, Inc.: 1 (https://510kreport.com/company/genesis-medical-interventional)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)

## Firms that cite its devices most
- Medos International SARL: 9 (https://510kreport.com/company/medos-international)
- Integra Lifesciences Production Corporation: 6 (https://510kreport.com/company/integra-lifesciences-production)
- Medtronic PS Medical: 5 (https://510kreport.com/company/medtronic-ps-medical)
- Aesculap, Inc.: 4 (https://510kreport.com/company/aesculap)
- Cerenovus, Inc.: 3 (https://510kreport.com/company/cerenovus)
- Integra LifeSciences Corporation: 3 (https://510kreport.com/company/integra-lifesciences)
- The Anspach Effort, Inc.: 3 (https://510kreport.com/company/anspach-effort)
- Elekta Instruments, Inc.: 2 (https://510kreport.com/company/elekta-instruments)

## Its most-cited devices
- K013877: Codman Slim-Loc System (2001), cited by 9
- K914479: Microsensor Intracranial Pressure Transducer (1994), cited by 6
- K071931: Codman Disposable Perforator, Model (S) 26-1222, 26-1223 (2007), cited by 5
- K020667: Codman Hakim Shunt Systems (2002), cited by 5
- K150319: Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant Microcoil Delivery Systems (2015), cited by 4
- K003322: Codman Bactiseal Catheters (2001), cited by 4

## Recent decisions
- K193380: CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set (Jul 20, 2020)
- K191237: CERENOVUS Large Bore Catheter (Nov 8, 2019)
- K173192: CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit (Nov 8, 2017)
- K172537: Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag (Oct 16, 2017)
- K172022: CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) (Oct 3, 2017)
- K171862: GALAXY G3 Mini Microcoil Delivery System (Sep 25, 2017)
- K171747: MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System,  MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System (Jul 14, 2017)
- K171653: YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (Jul 3, 2017)

Source page: https://510kreport.com/company/codman-shurtleff