Portex® Lancet Point Spinal Needles With NRFit™ Connectors, Portex® Pencil Point Spinal Needles With NRFit™ Connectors

Needle, Spinal, Short Term

Smiths Medical ASD, Inc.

The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Portex® Lancet Point Spinal Needles With Nrfit™ Connectors, Portex® Pencil Point Spinal Needles With Nrfit™ Connectors.

Pre-market Notification Details

• Device ID: K172800
• 510k Number: K172800
• Device Name: Portex® Lancet Point Spinal Needles With NRFit™ Connectors, Portex® Pencil Point Spinal Needles With NRFit™ Connectors
• Classification: Needle, Spinal, Short Term
• Applicant: Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442
• Contact: Michael R. Johnson
• Correspondent: Sunita Teekasingh; Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442
• Product Code: MIA
• CFR Regulation Number: 868.5150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-18
• Decision Date: 2018-06-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
55019517086780	K172800	000
55019517070697	K172800	000
35019517070686	K172800	000
35019517070679	K172800	000
55019517070666	K172800	000
35019517070655	K172800	000
35019517070648	K172800	000
95019517070633	K172800	000
35019517070600	K172800	000
35019517070570	K172800	000
35019517063534	K172800	000
35019517063527	K172800	000
55019517070734	K172800	000
35019517071430	K172800	000
35019517086755	K172800	000
55019517075036	K172800	000
55019517074978	K172800	000
35019517074943	K172800	000
35019517074110	K172800	000
75019517074101	K172800	000
35019517074097	K172800	000
35019517074011	K172800	000
75019517073852	K172800	000
35019517071454	K172800	000
35019517071447	K172800	000
55019517063477	K172800	000