Cleared Traditional

AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L

K013231 · Avid N.I.T., Inc. · Anesthesiology

Dec 2001

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K013231 is an FDA 510(k) clearance for the AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Avid N.I.T., Inc. (Oldsmar, US). The FDA issued a Cleared decision on December 3, 2001, 67 days after receiving the submission on September 27, 2001. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number	K013231 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2001
Decision Date	December 03, 2001
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement