CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
FDA 510(k) clearance K853770 · decided 1986-10-06
Clearance details
- K-number
- K853770
- Device name
- CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-09
- Decision date
- 1986-10-06
- Days to decision
- 392 days
- Clearance type
- Traditional
- Product code
- GWM
- Device class
- 2
- Regulation number
- 882.1620
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Randolph, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid Sc recall (Z-0708-2012) | Codman & Shurtleff, Inc. | 2012-01-11 |
| Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Ad recall (Z-0709-2012) | Codman & Shurtleff, Inc. | 2012-01-11 |
| Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw, Ped recall (Z-0710-2012) | Codman & Shurtleff, Inc. | 2012-01-11 |
| Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable dr recall (Z-2029-2011) | Codman & Shurtleff, Inc. | 2011-04-20 |
| Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use, dispo recall (Z-2031-2011) | Codman & Shurtleff, Inc. | 2011-04-20 |