TBI NEEDLE
FDA 510(k) clearance K860582 · decided 1986-03-04
Clearance details
- K-number
- K860582
- Device name
- TBI NEEDLE
- Applicant
- Hobbs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-18
- Decision date
- 1986-03-04
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- GAA
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Stafford Springs, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 462 recall (Z-0017-2023) | Hobbs Medical, Inc. | 2022-10-07 |
| Hobbs Transbronchial Aspiration Needle Catalog Number: 4621 recall (Z-0018-2023) | Hobbs Medical, Inc. | 2022-10-07 |