NEUROTUBE
FDA 510(k) clearance K983007 · decided 1999-03-22
Clearance details
- K-number
- K983007
- Device name
- NEUROTUBE
- Applicant
- Neuroregen, LLC
- Decision
- Substantially Equivalent
- Date received
- 1998-08-28
- Decision date
- 1999-03-22
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- JXI
- Device class
- 2
- Regulation number
- 882.5275
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bel Air, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240- recall (Z-1461-2023) | Baxter Healthcare Corporation | 2023-04-25 |