BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle

Needle, Conduction, Anesthetic (w/wo Introducer)

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Quincke Spinal Needle, Bd Whitacre Spinal Needle, Bd Spinal Introducer Needle.

Pre-market Notification Details

• Device ID: K210978
• 510k Number: K210978
• Device Name: BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
• Classification: Needle, Conduction, Anesthetic (w/wo Introducer)
• Applicant: Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417
• Contact: Nikita Abirami Mahendra Kumar
• Correspondent: Nikita Abirami Mahendra Kumar; Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417
• Product Code: BSP
• CFR Regulation Number: 868.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-01
• Decision Date: 2021-12-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382904003822	K210978	000
50382904003734	K210978	000
30382904003723	K210978	000
50382904003710	K210978	000