Cleared Traditional

AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE

K000117 · Avid Medical, Inc. · Obstetrics & Gynecology

Apr 2000

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K000117 is an FDA 510(k) clearance for the AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE, a Set, Anesthesia, Paracervical (Class II — Special Controls, product code HEE), submitted by Avid Medical, Inc. (Toano, US). The FDA issued a Cleared decision on April 13, 2000, 90 days after receiving the submission on January 14, 2000. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5100.

Submission Details

510(k) Number	K000117 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 14, 2000
Decision Date	April 13, 2000
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement