Identity
- Trade Name
- Hobbs Guiding Catheter FDA UDI
- Generic Name
- Endoscopic stent-placement system FDA UDI
- Device Name
- The Guiding Catheter is a sterile device inserted through a compatible flexible endoscope to aid in the initial placement of a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is made of polytetrafluoroethylene (PTFE) with a radiopaque marker on the distal end. This is a single-use device. FDA UDI
- Model / Reference
- 6130 FDA UDI
- Description
- The Guiding Catheter is a sterile device inserted through a compatible flexible endoscope to aid in the initial placement of a stent, typically into a pancreatic or biliary duct in order to maintain patency. It is made of polytetrafluoroethylene (PTFE) with a radiopaque marker on the distal end. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 6130 FDA UDI
- Primary DI / UDI-DI
- M84961300 FDA UDI
- 510(k) Number
- K834351 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Endoscopic stent-placement system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5010 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: Endoscopic stent-placement system
Hobbs Guiding Catheter by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscopic stent-placement system.
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- Oasis — Cook Ireland, Ltd. · Class II
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- Single Use Stent Insertion Kit V — Olympus Medical Systems Corporation · Class I
Cleared under the same submission
K834351 also covers:
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — HOBBS MEDICAL, INC.
- Freeman Pancreatic Flexi-Stent — 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 2071b254-aa2a-4a48-ba7e-833c56eee7d4 36 fields · synced May 30, 2026