FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
K Number: K242003
·
Decision Dec 16, 2024
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
207
Review Days
160
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Basic Information
- Device Name
- XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
- K Number
- K242003
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesculap, Inc.
- Date Received
- July 9, 2024
- Decision Date
- December 16, 2024
- Product Code
- JXG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
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| K203739 | ELAN 4 Electro Motor System | Aug 24, 2021 | Substantially Equivalent |
| K202391 | DIR 800 | Jan 21, 2021 | Substantially Equivalent |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology System | Dec 18, 2020 | Substantially Equivalent |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology System | Oct 30, 2020 | Substantially Equivalent |
| K202124 | Aesculap PAS-Port Proximal Anastomosis System | Sep 2, 2020 | Substantially Equivalent |
| K200950 | Ventricular Catheter | May 8, 2020 | Substantially Equivalent |