Identity
- Trade Name
- WayPoint™ Depth Stop FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- WayPoint 1.8mm Depth Stop FDA UDI
- Model / Reference
- 66-DS-MO-00544 FDA UDI
- Description
- WayPoint 1.8mm Depth Stop FDA UDI
Identifiers
- Catalog Number
- 66-DS-MO FDA UDI
- Primary DI / UDI-DI
- 00873263005446 FDA UDI
- 510(k) Number
- K092192 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 1.8 Millimeter FDA UDI
WayPoint™ Depth Stop by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092192 also covers:
- MicroTargeting™ RPD Adapter — FHC, INC.
- MicroTargeting™ Sterilization Basket — FHC, INC.
- OsteoMed™ Manual Driver Handle — FHC, INC.
- STar™ Drive Lead Measurement Fixture — FHC, INC.
- WayPoint™ Anchors — FHC, INC.
- WayPoint™ Anchors — FHC, INC.
- WayPoint™ Combination Driver Bit — FHC, INC.
- WayPoint™ Hex Wrench — FHC, INC.
- WayPoint™ Implantation Kit — FHC, INC.
- WayPoint™ Multi-Oblique Platform — FHC, INC.
- WayPoint™ Navigator — FHC, INC.
- WayPoint™ Navigator — FHC, 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
- Fhc, Inc.
Sources (1)
- FDA UDI 9ebc28e2-ae66-4b53-a8d5-652621c635c5 39 fields · synced Jun 6, 2026