Identity
- Trade Name
- QEVO FDA UDI
- Generic Name
- Rigid optical intracranial/spinal endoscope, reusable FDA UDI
- Model / Reference
- 7212 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539072122 FDA UDI
- 510(k) Number
- K170667 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Rigid optical intracranial/spinal endoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Rigid optical intracranial/spinal endoscope, reusable
Qevo by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical intracranial/spinal endoscope, reusable.
- TIPCAM — Karl Storz GmbH & Co. KG · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- ENDOCAMELEON — Karl Storz GmbH & Co. KG · Class II
- LOTTA — Karl Storz GmbH & Co. KG · Class II
- AESCULAP — AESCULAP, INC. · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
Cleared under the same submission
K170667 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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 4d2e037a-2c7a-49d8-a734-21e3eb8a39fc 33 fields · synced Jun 8, 2026