BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit 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 Nrfit Needle, Bd Whitacre Spinal Nrfit Needle, Bd Spinal Introducer Nrfit Needle.

Pre-market Notification Details

• Device ID: K193131
• 510k Number: K193131
• Device Name: BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
• Classification: Needle, Conduction, Anesthetic (w/wo Introducer)
• Applicant: Becton, Dickinson And Company 1 Becton Drive Franklin Lakes, NJ 07417
• Contact: Murtaza Rana
• Correspondent: Murtaza Rana; 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: 2019-11-12
• Decision Date: 2020-09-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30382904009213	K193131	000
50382904009897	K193131	000
50382904000535	K193131	000
50382904009750	K193131	000
30382904009725	K193131	000
50382904009712	K193131	000
50382904009705	K193131	000
30382904009244	K193131	000
30382904009237	K193131	000
30382904009220	K193131	000
30382904001811	K193131	000
50382904000887	K193131	000
30382904000586	K193131	000
30382904000562	K193131	000
30382904009909	K193131	000
30382904000579	K193131	000
50382904000597	K193131	000
50382904009200	K193131	000
30382904000548	K193131	000
50382904000528	K193131	000
50382904009835	K193131	000
30382904009817	K193131	000
30382904009770	K193131	000
30382904009763	K193131	000
30382904009749	K193131	000
30382904009732	K193131	000
50382904000870	K193131	000
50382904000818	K193131	000
30382904000623	K193131	000
30382904000609	K193131	000
30382904000555	K193131	000