16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE— 510(k) K894878

Substantially Equivalent

R. J. Doyle, Inc.

FDA 510(k) clearance K894878 for 16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE, Substantially Equivalent on 1989-11-30. Applicant: R. J. Doyle, Inc..

Clearance details

Applicant: R. J. Doyle, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1989-08-01
Decision date: 1989-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spirit Lake, ID, US

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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.