HOBBS MISTIFIER SPRAY CATHETER
FDA 510(k) clearance K030765 · decided 2003-06-09
Clearance details
- K-number
- K030765
- Device name
- HOBBS MISTIFIER SPRAY CATHETER
- Applicant
- Hobbs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-11
- Decision date
- 2003-06-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Stafford Springs, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedur recall (Z-0010-2023) | Hobbs Medical, Inc. | 2022-10-07 |
| Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedur recall (Z-0011-2023) | Hobbs Medical, Inc. | 2022-10-07 |