Identity
- Trade Name
- Hobbs Helical Retrieval Basket FDA UDI
- Generic Name
- Flexible endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- A flexible manual device used in combination with a compatible endoscope to grasp foreign bodies. It is constructed of a flexible metal coil and plastic tube whose distal end is equipped with a helical shaped basket which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device. FDA UDI
- Model / Reference
- 4822 FDA UDI
- Description
- A flexible manual device used in combination with a compatible endoscope to grasp foreign bodies. It is constructed of a flexible metal coil and plastic tube whose distal end is equipped with a helical shaped basket which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- 4822 FDA UDI
- Primary DI / UDI-DI
- M84948220 FDA UDI
- 510(k) Number
- K833124 FDA UDI
- FDA Product Code
- OCZ FDA UDI
- GMDN Term
- Flexible endoscopic tissue manipulation forceps, reusable 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
No
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
Liquid Chemical FDA UDI
Category: Flexible endoscopic tissue manipulation forceps, reusable
Hobbs Helical Retrieval Basket by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Flexible endoscopic tissue manipulation forceps, reusable.
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- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
Cleared under the same submission
K833124 also covers:
- Hobbs Helical Retrieval Basket — HOBBS MEDICAL, INC.
- Hobbs Helical Retrieval Basket — HOBBS MEDICAL, INC.
- Hobbs Helical Retrieval Basket — HOBBS MEDICAL, INC.
- Hobbs Helical Retrieval Basket — HOBBS MEDICAL, INC.
- Hobbs Helical Retrieval Basket — HOBBS MEDICAL, INC.
- Hobbs Helical Retrieval Basket — HOBBS MEDICAL, INC.
- Hobbs Helical Retrieval Basket — HOBBS MEDICAL, INC.
- Hobbs Helical Retrieval Basket Handle — 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 d799ba3f-1313-4072-b8a8-6b66b1e40637 36 fields · synced Jun 7, 2026