PINPOINT NEEDLE— 510(k) K853478

Substantially Equivalent

Regional Master Corp.

FDA 510(k) clearance K853478 for PINPOINT NEEDLE, Substantially Equivalent on 1986-01-15. Applicant: Regional Master Corp..

Clearance details

Applicant: Regional Master Corp.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1985-08-14
Decision date: 1986-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.