Identity
- Trade Name
- Stealth Autoguide FDA UDI
- Generic Name
- Multi-purpose stereotactic surgery system FDA UDI
- Device Name
- SYSTEM 29631 STEALTH AUTOGUIDE ENG ONLY FDA UDI
- Model / Reference
- 29631 FDA UDI
- Description
- SYSTEM 29631 STEALTH AUTOGUIDE ENG ONLY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000705008 FDA UDI
- 510(k) Number
- K191597 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Multi-purpose stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-purpose stereotactic surgery system
Stealth Autoguide by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-purpose stereotactic surgery system.
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Cleared under the same submission
K191597 also covers:
- Autoguide — MEDTRONIC NAVIGATION, INC.
- Autoguide — MEDTRONIC NAVIGATION, INC.
- Autoguide — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
- Stealth Autoguide™ System — MEDTRONIC NAVIGATION, INC.
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
- Medtronic Navigation, Inc.
Sources (1)
- FDA UDI 468b78c3-7589-4095-a530-1abc079682f7 35 fields · synced Jun 8, 2026