TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK— 510(k) K864830

Substantially Equivalent

Professional Instruments Co.

FDA 510(k) clearance K864830 for TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK, Substantially Equivalent on 1987-01-12. Applicant: Professional Instruments Co..

Clearance details

Applicant: Professional Instruments Co.
Product code: Code BXN
Advisory panel: Anesthesiology
Date received: 1986-12-09
Decision date: 1987-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code BXN

product code BXN

Other: 1
Total: 1

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.