Identity
- Trade Name
- StimSite FDA UDI
- Generic Name
- Nerve-locating system FDA UDI
- Device Name
- Activation Card, StimSite, Single FDA UDI
- Model / Reference
- AM 2101 FDA UDI
- Description
- Activation Card, StimSite, Single FDA UDI
Identifiers
- Catalog Number
- AM 2101 FDA UDI
- Primary DI / UDI-DI
- 00860002926919 FDA UDI
- 510(k) Number
- FDA Product Code
- ETN FDA 510(k)FDA UDI
- GMDN Term
- Nerve-locating system FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 874.1820 FDA 510(k)
- Regulation Number
- 874.1820 FDA 510(k)FDA UDI
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
StimSite by Allotrope Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200886 | Class II | Active |
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Manufacturer
- Manufacturer
- Allotrope Medical, Inc.
Sources (2)
- FDA 510(k) K200886 24 fields · synced Jun 18, 2026
- FDA UDI c0646cf2-602c-451c-92fd-621c57001b06 35 fields · synced May 27, 2026