Identity
- Trade Name
- Endoscopic Cytology Brush FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Model / Reference
- 07-9001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00874485003180 FDA UDI
- 510(k) Number
- K834402 FDA UDI
- FDA Product Code
- FDX FDA UDI
- GMDN Term
- Flexible endoscopic cytology brush, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Endoscopic Cytology Brush by Cogentix Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K834402 also covers:
- Hobbs Medical Cytology Brush — HOBBS MEDICAL, INC.
- Hobbs Medical Cytology Brush — HOBBS MEDICAL, INC.
- Hobbs Medical Cytology Brush — HOBBS MEDICAL, INC.
- Hobbs Medical Cytology Brush — HOBBS MEDICAL, INC.
- Hobbs Medical Cytology Brush — HOBBS MEDICAL, INC.
- Hobbs Medical Cytology Brush — HOBBS MEDICAL, 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
- Cogentix Medical, Inc.
Sources (1)
- FDA UDI c5d5c2bf-36db-41eb-9c18-4c8243f7f5a7 35 fields · synced Jun 6, 2026