Codman®
CODMAN® HEWLETT-PACKARD 12 Pin /Red Interface Cable
5manufacturers in China registered for this device type
19catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| PAN-International Precision Electronic Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | GWM |
| Device type | Device, Monitoring, Intracranial Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1620 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K840003 |
| Record published | 2020-04-01 |
| Record revised | 2026-02-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 68 to 77 °F; Storage environment temperature 68 to 77 °F |
| Distribution end date | 2023-05-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 926654 | In distribution | |
| NS9011 | In distribution | |
| 826646 | In distribution | |
| 826645 | In distribution | |
| 826642 | In distribution | |
| 826616 | In distribution | |
| 826608 | In distribution | |
| 826647 | In distribution | |
| 926628 | In distribution | |
| 826614 | In distribution | |
| 826607 | In distribution | |
| 926637 | In distribution | |
| 826609 | In distribution | |
| 826643 | In distribution | |
| 926640 | In distribution | |
| 826612 | In distribution | |
| 801190 | Withdrawn | |
| 801196 | Withdrawn | |
| 801197 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Licox® | GMS, Gesellschaft für medizinische Sondentechnik mbH | 38 |
| Sophysa | Sophysa | 32 |
| Becker® | Medtronic PS Medical | 31 |
| Codman | Cerenovus, Inc. | 29 |
| Device, Monitoring, Intracranial Pressure | Medtronic PS Medical | 28 |
| Exacta™ | Medtronic PS Medical | 28 |
| Braincare | Braincare Desenvolvimento E Inovacao Tecnologica SA | 24 |
| Camino® | Integra Lifesciences (Ireland) Limited | 20 |
| Integra® | Integra Lifesciences (Ireland) Limited | 17 |
| Aura | Branchpoint & Aura Development LLC | 17 |
| Natus | Natus Medical Incorporated | 15 |
| Duet® | Medtronic PS Medical | 14 |
Showing 12 of 133. All products under Device, Monitoring, Intracranial Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232890 | 2024-02-04 |
| K210993 | 2021-04-30 |
Recalls Naming This Product
10 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2023-04-11 | Class II | Under Investigation by firm | Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or | 337 units | |
| Integra Lifesciences Corporation | UDI-DI | 2022-01-21 | Class II | Under Investigation by firm | Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur | 1161 kits | 2024-03-19 |
| Integra Lifesciences Corporation | UDI-DI | 2022-01-21 | Class II | Under Investigation by firm | Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur | 1160 kits | 2024-03-19 |
| Cerenovus, Inc. | 510(k) number | 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 861 units | 2015-05-29 |
| Cerenovus, Inc. | 510(k) number | 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 13845 units | 2015-05-29 |
| Cerenovus, Inc. | 510(k) number | 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 2827 units | 2015-05-29 |
| Cerenovus, Inc. | 510(k) number | 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 462 units | 2015-05-29 |
| Cerenovus, Inc. | 510(k) number | 2011-10-25 | Not classified | Labeling Change Control | Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits. | 254 units | 2015-05-29 |
| Cerenovus, Inc. | 510(k) number | 2010-11-30 | Not classified | Package design/selection | Packaging defect may compromise sterility of device | 2264 units | 2013-03-14 |
| Cerenovus, Inc. | 510(k) number | 2010-11-30 | Not classified | Package design/selection | Packaging defect may compromise sterility of device | 226 units | 2013-03-14 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.