TBI NEEDLE— 510(k) K860582

Substantially Equivalent

Hobbs Medical, Inc.

FDA 510(k) clearance K860582 for TBI NEEDLE, Substantially Equivalent on 1986-03-04. Applicant: Hobbs Medical, Inc..

Clearance details

Applicant: Hobbs Medical, Inc.
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 1986-02-18
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stafford Springs, CT, US

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.