POLYMEDIC SPINAL NEEDLE AND INTRODUCER— 510(k) K940061

Name: FDA 510(k) clearance K940061
Creator: U.S. Food and Drug Administration
Published: 1995-12-21

Substantially Equivalent

Techniques Medicales DE Navaree

FDA 510(k) clearance K940061 for POLYMEDIC SPINAL NEEDLE AND INTRODUCER, Substantially Equivalent on 1995-12-21. Applicant: Techniques Medicales DE Navaree. Device class: 2.

Clearance details

Applicant: Techniques Medicales DE Navaree
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 1994-01-06
Decision date: 1995-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, 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.