Identity
- Trade Name
- S3D OTI Camera FDA UDI
- Generic Name
- Optical surgical navigation device tracking system FDA UDI
- Model / Reference
- EMA0001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290019120261 FDA UDI
- 510(k) Number
- K222355 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Optical surgical navigation device tracking 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Optical surgical navigation device tracking system
S3D OTI Camera by Pathkeeper Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222355 also covers:
- PKS Accessories Setup DRF — PATHKEEPER SURGICAL LTD
- PKS Accessories Setup DRF — PATHKEEPER SURGICAL LTD
- PKS DRF 2 - ID 5.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 2-ID5.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 2-ID6.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 3 - ID 12.2 — PATHKEEPER SURGICAL LTD
- PKS DRF 3-ID12.2 — PATHKEEPER SURGICAL LTD
- PKS DRF 3-ID15 — PATHKEEPER SURGICAL LTD
- PKS DRF 3-ID15 — PATHKEEPER SURGICAL LTD
- PKS DRF 4 - ID 7.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 4-ID7.9 — PATHKEEPER SURGICAL LTD
- PKS DRF 4-ID9.5x8 — PATHKEEPER SURGICAL LTD
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
- Pathkeeper Surgical Ltd
Sources (1)
- FDA UDI 4a291bb5-45e2-4528-a5f5-2ea723ec0d0e 33 fields · synced May 30, 2026