AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L— 510(k) K013231

Substantially Equivalent

Avid N.I.T., Inc.

FDA 510(k) clearance K013231 for AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L, Substantially Equivalent on 2001-12-03. Applicant: Avid N.I.T., Inc..

Clearance details

Applicant: Avid N.I.T., Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2001-09-27
Decision date: 2001-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oldsmar, 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.