Identity
- Trade Name
- Hobbs Microbiology Brush FDA UDI
- Generic Name
- Flexible endoscopic cytology brush, single-use FDA UDI
- Device Name
- The Hobbs Microbiology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil inside a plastic tube, whose distal end is equipped with plastic bristles for harvesting and protecting mucosal cells, e.g., during endoscopy. This is a single-use device. FDA UDI
- Model / Reference
- 4310 FDA UDI
- Description
- The Hobbs Microbiology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil inside a plastic tube, whose distal end is equipped with plastic bristles for harvesting and protecting mucosal cells, e.g., during endoscopy. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 4310 FDA UDI
- Primary DI / UDI-DI
- M84943100 FDA UDI
- 510(k) Number
- K893729 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
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Flexible endoscopic cytology brush, single-use
Hobbs Microbiology Brush by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic cytology brush, single-use.
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- CONMED — Conmed Corporation · Class II
- CONMED — Conmed Corporation · Class I
- DISPOSABLE CYTOLOGY BRUSH — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K893729 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
- Hobbs Medical, Inc.
Sources (1)
- FDA UDI 59f070d8-5c7b-46e3-93d7-a7c41cb493d5 36 fields · synced Jun 8, 2026