TBI NEEDLE— 510(k) K860582
Substantially EquivalentHobbs Medical, Inc.
FDA 510(k) clearance K860582 for TBI NEEDLE, Substantially Equivalent on 1986-03-04. Applicant: Hobbs Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Hobbs Medical, Inc.
- Product code
- Code GAA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4800
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stafford Springs, CT, US
Recent devices under product code GAA
view allMore clearances from Hobbs Medical, Inc.
view allAdverse events under product code GAA
product code GAA- Malfunction
- 834
- Total
- 834
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K860582
K-number listed on FDA's recall record- Z-0017-2023 — Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
- Z-0018-2023 — Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K860582.
Data sourced from openFDA. This site is unofficial and independent of the FDA.