Cleared Traditional

BD Epilor Syringe

K210983 · Becton, Dickinson and Company · Anesthesiology

May 2022

Decision

413d

Days

Class 2

Risk

About This 510(k) Submission

K210983 is an FDA 510(k) clearance for the BD Epilor Syringe, a Anesthesia Conduction Kit (Class II — Special Controls, product code CAZ), submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on May 19, 2022, 413 days after receiving the submission on April 1, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5140.

Submission Details

510(k) Number	K210983 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2021
Decision Date	May 19, 2022
Days to Decision	413 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CAZ — Anesthesia Conduction Kit
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5140
Definition	This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.