Hobbs Helical Retrieval Basket Handle
A control handle for a flexible manual device used in combination with a compatible endoscope to grasp foreign bodies. The device is constructed of a flexible metal coil and plastic tube…
A control handle for a flexible manual device used in combination with a compatible endoscope to grasp foreign bodies. The device 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.
6manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
18recalls on this code
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
Record
| Listed by | Hobbs Medical, Inc., United States |
|---|---|
| FDA product code | OCZ |
| Device type | Endoscopic Grasping/Cutting Instrument, Non-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| 510(k) | K833124 |
| Record published | 2016-09-21 |
| Record revised | 2025-12-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Liquid Chemical |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2018-04-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4850 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Stryker GmbH | 176 |
| Single Use Grasping Forceps | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 53 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Karl Storz GmbH & Co. KG | 42 |
| Hobbs Medical Polypectomy Snare | Hobbs Medical, Inc. | 27 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | Richard Wolf Gmbh | 24 |
| Hysafe | Richard Wolf Gmbh | 22 |
| Grasping Forceps | Olympus Medical Systems Corp. | 17 |
| EndoTBasket | Endo-Therapeutics, Inc. | 13 |
| Halyard | Avanos Medical, Inc. | 11 |
| Hobbs Helical Retrieval Basket | Hobbs Medical, Inc. | 8 |
| Grasping Forceps | Micro-Tech (Nanjing) Co., Ltd. | 6 |
| Foreign Body Grasping Forceps | Avanos Medical, Inc. | 6 |
Showing 12 of 31. All products under Endoscopic Grasping/Cutting Instrument, Non-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K844074 | 1985-01-03 |
| K833124 | 1983-11-29 |
| K833125 | 1983-10-31 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 4 units |
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 2 units |
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 3 units |
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 10 units |
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 14 units |
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 10 units |
| Hobbs Medical, Inc. | 510(k) number | 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 13 units |
Recalls
11 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 4 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 10 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 14 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 35 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 30 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 100 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 20 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 10 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 3 units |
| 2022-07-29 | Class II | Process control | Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot | 7 units |
| 2022-06-03 | Class II | Component design/selection | During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result. | 45 (US) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.