Codman & Shurtleff, Inc.: FDA filings under this applicant name
FDA lists 153 510(k) clearances under 2 spellings of the applicant name “Codman & Shurtleff, Inc.” (first 1976, latest 2020), across 62 product codes in 11 review panels. Median 510(k) review time under this name: 67 days. Since 2017 the median was 90 days, against 109 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 31 |
| 2013 | 2 | 52 |
| 2014 | 4 | 95 |
| 2015 | 2 | 92 |
| 2016 | 2 | 166 |
| 2017 | 7 | 55 |
| 2018 | 0 | — |
| 2019 | 1 | 184 |
| 2020 | 1 | 228 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Codman & Shurtleff, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 109 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 23 | 23 |
| GWM | Device, Monitoring, Intracranial Pressure | 9 | 9 |
| DQY | Catheter, Percutaneous | 8 | 8 |
| HCG | Device, Neurovascular Embolization | 8 | 8 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 5 | 5 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 5 | 5 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 4 | 4 |
| HCH | Clip, Aneurysm | 4 | 4 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 4 | 4 |
Plus 52 more product codes.
Review panels
- Neurology (85)
- General and Plastic Surgery (15)
- Cardiovascular (14)
- Orthopedic (12)
- Ophthalmic (8)
- Gastroenterology and Urology (5)
- General Hospital (4)
- Radiology (4)
- Dental (3)
- Microbiology (1)
- Obstetrics and Gynecology (1)
Most recent Codman & Shurtleff, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | NRY | 2020-07-20 | 228 |
| K191237 | CERENOVUS Large Bore Catheter | DQY | 2019-11-08 | 184 |
| 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 | GWM | 2017-11-08 | 37 |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag | JXG | 2017-10-16 | 55 |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | JXG | 2017-10-03 | 90 |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | HCG | 2017-09-25 | 95 |
| 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 | HCG | 2017-07-14 | 31 |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | DQY | 2017-07-03 | 28 |
| K162563 | YOGA Microcatheter | DQY | 2017-01-05 | 113 |
| K162437 | Codman EDS3 CSF External Drainage System | JXG | 2016-10-28 | 58 |
143 earlier clearances. See the full list in Caduvo.
Recalls
78 product recalls in 18 recall events; 0 initiated in the last five years. Most recent: 2019-05-16.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Codman & Shurtleff, Inc. is the lead sponsor of 11 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02169492: Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke (Completed, started 2015-01-01)
- NCT01259271: Selective Nerve Stimulation (SNS) Pilot Study (Completed, started 2010-11-01)
- NCT00486226: The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System (Completed, started 2007-06-01)
- NCT00349908: A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries (Completed, started 2006-09)
- NCT00280904: A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus (Completed, started 2006-01)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Codman & Shurtleff, Inc. (152)
- Codman and Shurtleff, Inc. (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Codman & Shurtleff, Inc.?
FDA lists 153 510(k) clearances under 2 spellings of the applicant name “Codman & Shurtleff, Inc.” (first 1976, latest 2020), across 62 product codes in 11 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Codman & Shurtleff, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Codman & Shurtleff, Inc. is 67 days. Since 2017: 90 days, versus 109 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Codman & Shurtleff, Inc.?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 23); GWM (Device, Monitoring, Intracranial Pressure, 9); DQY (Catheter, Percutaneous, 8).
Next steps
- See all 153 Codman & Shurtleff, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JXG, Codman & Shurtleff, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.