Identity
- Trade Name
- Hobbs Achalasia Dilation Balloon FDA UDI
- Generic Name
- Oesophageal balloon catheter FDA UDI
- Device Name
- A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device. FDA UDI
- Model / Reference
- 3302 FDA UDI
- Description
- A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 3302 FDA UDI
- Primary DI / UDI-DI
- M84933020 FDA UDI
- 510(k) Number
- K834413 FDA UDI
- FDA Product Code
- KNQ FDA UDI
- GMDN Term
- Oesophageal balloon catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5365 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: Oesophageal balloon catheter
Hobbs Achalasia Dilation Balloon by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal balloon catheter.
- Elation™ — Merit Medical Systems, Inc. · Class II
- XXL™ Esophageal — Boston Scientific · Class II
- XXL™ Esophageal — Boston Scientific · Class II
- XXL™ Esophageal — Boston Scientific · Class II
- Elation™ — Merit Medical Systems, Inc. · Class II
- Elation™ — Merit Medical Systems, Inc. · Class II
- XXL™ Esophageal — Boston Scientific · Class II
- Elation™ — Merit Medical Systems, Inc. · Class II
Cleared under the same submission
K834413 also covers:
- Biliary Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Biliary Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Biliary Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — HOBBS MEDICAL, INC.
- Flex-Ez Over the Wire Balloon Dilator — 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
- Hobbs Medical, Inc.
Sources (1)
- FDA UDI 09c0983a-d1ed-436a-8a5d-78d5c917390a 36 fields · synced Jun 8, 2026