Identity
- Trade Name
- Freeman Pancreatic Flexi-Stent FDA UDI
- Generic Name
- Polymeric pancreatic stent, non-bioabsorbable FDA UDI
- Device Name
- A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device. FDA UDI
- Model / Reference
- 6575 FDA UDI
- Description
- A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 6575 FDA UDI
- Primary DI / UDI-DI
- M84965750 FDA UDI
- 510(k) Number
- K834351 FDA UDI
- FDA Product Code
- FGE FDA UDI
- GMDN Term
- Polymeric pancreatic stent, non-bioabsorbable 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
Yes
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
MR Safe FDA UDI
Category: Polymeric pancreatic stent, non-bioabsorbable
Freeman Pancreatic Flexi-Stent by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric pancreatic stent, non-bioabsorbable.
- Johlin — Cook Ireland, Ltd. · Class II
- PANCREATIC STENT — Olympus Medical Systems Corporation · Class II
- Advanix™ Pancreatic Stent — Boston Scientific · Class II
- Advanix™ Pancreatic Stent — Boston Scientific · Class II
- Geenen — Cook Ireland, Ltd. · Class II
- Geenen — Cook Ireland, Ltd. · Class II
- Geenen — Cook Ireland, Ltd. · Class II
- Geenen — Cook Ireland, Ltd. · Class II
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 913bc97e-8f03-4c2a-8bd7-92978000f892 36 fields · synced May 29, 2026