Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Codman & Shurtleff, Inc. — Predicate Candidate Screening
152 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
230 days90th percentile
152clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing S | Codman & Shurtleff, Inc. | 2020-07-20 | 228 | 0 |
| K191237 | CERENOVUS Large Bore Catheter | Codman & Shurtleff, Inc. | 2019-11-08 | 184 | 0 |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Sku | Codman & Shurtleff, Inc. | 2017-11-08 | 37 | 1 |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF | Codman & Shurtleff, Inc. | 2017-10-16 | 55 | 0 |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundle | Codman & Shurtleff, Inc. | 2017-10-03 | 90 | 0 |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | Codman & Shurtleff, Inc. | 2017-09-25 | 95 | 0 |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, | Codman & Shurtleff, Inc. | 2017-07-14 | 31 | 0 |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | Codman & Shurtleff, Inc. | 2017-07-03 | 28 | 0 |
| K162563 | YOGA Microcatheter | Codman & Shurtleff, Inc. | 2017-01-05 | 113 | 0 |
| K162437 | Codman EDS3 CSF External Drainage System | Codman & Shurtleff, Inc. | 2016-10-28 | 58 | 2 |
| K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Sku | Codman & Shurtleff, Inc. | 2016-08-19 | 273 | 1 |
| K152481 | DURAFORM Dural Graft Implant | Codman & Shurtleff, Inc. | 2015-10-30 | 60 | 1 |
| K150319 | MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FIL | Codman & Shurtleff, Inc. | 2015-06-12 | 123 | 0 |
| K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delive | Codman & Shurtleff, Inc. | 2014-12-24 | 117 | 0 |
| K140080 | ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, | Codman & Shurtleff, Inc. | 2014-04-24 | 100 | 0 |
| K140307 | ENVOY GUIDING CATHETER | Codman & Shurtleff, Inc. | 2014-04-21 | 73 | 0 |
| K133625 | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STAND | Codman & Shurtleff, Inc. | 2014-02-24 | 90 | 0 |
| K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | Codman & Shurtleff, Inc. | 2013-08-30 | 38 | 0 |
| K123560 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUF | Codman & Shurtleff, Inc. | 2013-01-25 | 67 | 0 |
| K121776 | AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE | Codman & Shurtleff, Inc. | 2012-08-14 | 57 | 0 |
| K122118 | HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM | Codman & Shurtleff, Inc. | 2012-08-03 | 17 | 0 |
| K120117 | CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM | Codman & Shurtleff, Inc. | 2012-04-16 | 90 | 1 |
| K120686 | ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM | Codman & Shurtleff, Inc. | 2012-04-04 | 29 | 0 |
| K120229 | ENVOY DISTAL ACCESS GUIDING CATHETER | Codman & Shurtleff, Inc. | 2012-02-24 | 30 | 0 |
| K112828 | REVIVE INTERMEDIATE CATHETER (REVIVE IC) | Codman & Shurtleff, Inc. | 2011-10-25 | 27 | 0 |
| K110751 | CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER | Codman & Shurtleff, Inc. | 2011-05-09 | 52 | 0 |
| K102961 | HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERV | Codman & Shurtleff, Inc. | 2011-02-18 | 136 | 0 |
| K102589 | CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER | Codman & Shurtleff, Inc. | 2011-01-14 | 127 | 0 |
| K093973 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | Codman & Shurtleff, Inc. | 2010-05-26 | 153 | 0 |
| K092437 | CODMAN STERILIZATION CONTAINERS | Codman & Shurtleff, Inc. | 2010-03-25 | 230 | 0 |
| K100351 | NEUROSCOUT STEERABLE GUIDEWIRE | Codman & Shurtleff, Inc. | 2010-03-16 | 32 | 0 |
| K093184 | ENVOY GUIDING CATHETERS | Codman & Shurtleff, Inc. | 2009-11-06 | 28 | 0 |
| K091921 | CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN | Codman & Shurtleff, Inc. | 2009-09-08 | 70 | 0 |
| K083895 | CODMAN ISOCOOL BIPOLAR FORCEPS | Codman & Shurtleff, Inc. | 2009-06-23 | 176 | 0 |
| K091346 | CODMAN HAKIM MICRO II VALVE | Codman & Shurtleff, Inc. | 2009-06-02 | 26 | 0 |
| K090348 | CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EV | Codman & Shurtleff, Inc. | 2009-03-04 | 21 | 0 |
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | Codman & Shurtleff, Inc. | 2008-01-04 | 37 | 1 |
| K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | Codman & Shurtleff, Inc. | 2007-10-22 | 101 | 0 |
| K071791 | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 | Codman & Shurtleff, Inc. | 2007-07-30 | 28 | 0 |
| K071776 | ANEUROPLASTIC, MODEL 43-1290 | Codman & Shurtleff, Inc. | 2007-07-26 | 27 | 0 |
| K061876 | CODMAN VPV SYSTEM, MODEL 82-3192 | Codman & Shurtleff, Inc. | 2006-10-16 | 105 | 0 |
| K061568 | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 8 | Codman & Shurtleff, Inc. | 2006-09-29 | 115 | 3 |
| K053107 | CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD | Codman & Shurtleff, Inc. | 2006-01-19 | 76 | 0 |
| K053350 | MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS | Codman & Shurtleff, Inc. | 2006-01-19 | 48 | 0 |
| K052449 | CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MO | Codman & Shurtleff, Inc. | 2005-10-17 | 41 | 0 |
| K050739 | CODMAN VPV SYSTEM, MODEL 82-3192 | Codman & Shurtleff, Inc. | 2005-07-18 | 119 | 0 |
| K041518 | CODMAN DURAFORM DURAL GRAFT IMPLANT | Codman & Shurtleff, Inc. | 2004-06-22 | 15 | 0 |
| K041296 | MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMM | Codman & Shurtleff, Inc. | 2004-06-10 | 27 | 0 |
| K033395 | CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473 | Codman & Shurtleff, Inc. | 2004-02-25 | 125 | 0 |
| K023566 | CODMAN ISOCOOL BIPOLAR FORCEPS | Codman & Shurtleff, Inc. | 2003-05-22 | 211 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda