Identity
- Trade Name
- MindsEye Expandable Port FDA UDI
- Generic Name
- Neurosurgical retraction cannula FDA UDI
- Device Name
- subcortical access sheath 5.2 cm FDA UDI
- Model / Reference
- 5.2cm FDA UDI
- Description
- subcortical access sheath 5.2 cm FDA UDI
Identifiers
- Catalog Number
- N-EXP1A-052 FDA UDI
- Primary DI / UDI-DI
- 00860003476826 FDA UDI
- 510(k) Number
- K202072 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Neurosurgical retraction cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 5.2 Centimeter FDA UDI
Category: Neurosurgical retraction cannula
MindsEye Expandable Port by Minnetronix Neuro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurosurgical retraction cannula.
- NICO BrainPath — NICO Corporation · Class II
- Vycor Viewsite Brain Access System with Alignment Clip — Vycor Medical, Inc. · Class II
- NICO BrainPath — NICO Corporation · Class II
- NICO BrainPath — NICO Corporation · Class II
- NICO BrainPath — NICO Corporation · Class II
- Vycor Viewsite Brain Access System with Alignment Clip — Vycor Medical, Inc. · Class II
- Vycor Viewsite Brain Access System with Alignment Clip — Vycor Medical, Inc. · Class II
- NICO BrainPath — NICO Corporation · Class II
Cleared under the same submission
K202072 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Minnetronix Neuro, Inc.
Sources (1)
- FDA UDI 765ff61a-0a33-4e05-aedd-79cde0a1b831 38 fields · synced Jun 8, 2026