510(k) K983858

Device: SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES
Applicant: SIMS PORTEX, INC.
510(k) number: K983858
Product code: MIA
Decision: Substantially Equivalent (SESE)
Decision date: 1999-01-29
Date received: 1998-11-02
Regulation: 868.5150
Classification name: Needle, Spinal, Short Term
Medical specialty: Anesthesiology
Review panel: Anesthesiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: TIMOTHY J TALCOTT
Address: 10 Bowman Dr. Keene NH US 03431 03431

FDA Registration Numbers#

1721676
3003604053
1047429
9617604
1061124
1219602
1224960
3020983482
3012307300
1644312
3011237704
1319639
1643059
3008132398
3004111573
1030451
3035642068
1423537
9681709
3005941719
9616088
1721686
3004504731
1316297
3010966701
1423507

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
15019517130584	Portex	ICU MEDICAL, INC.	2017-12-07
15019517039757	Portex	ICU MEDICAL, INC.	2017-12-07
20351688051704	Portex	ICU MEDICAL, INC.	2017-01-09
10351688061362	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09
20351688061284	Portex	ICU MEDICAL, INC.	2017-01-09
20351688061291	Portex	ICU MEDICAL, INC.	2017-01-09
20351688061307	Portex	ICU MEDICAL, INC.	2017-01-09
20351688061314	Portex	ICU MEDICAL, INC.	2017-01-09
20351688061321	Portex	ICU MEDICAL, INC.	2017-01-09
20351688061338	Portex	ICU MEDICAL, INC.	2017-01-09
20351688061352	Portex	ICU MEDICAL, INC.	2017-01-09
20351688061369	Portex	ICU MEDICAL, INC.	2017-01-09
10351688051707	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09
10351688061287	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09
10351688061294	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09
10351688061300	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09
10351688061317	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09
10351688061324	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09
10351688061331	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09
10351688061355	Portex	SMITHS MEDICAL ASD, INC.	2017-01-09

Other 510(k) Records For Product Code MIA #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K172800	Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors	Smiths Medical Asd, Inc.	2018-06-14
K051860	FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837	Epimed International, Inc.	2005-08-22
K982269	CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA	Allegiance Healthcare Corp.	1998-07-23
K971645	REGANES SPINAL NEEDLE (VARIOUS)	Avid N.I.T., Inc.	1997-08-01
K970997	NEO-CARE LUMBER PUNCTURE KIT	Klein-Baker Medical, Inc.	1997-05-22
K961324	GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES	Global Medical Prods, Inc.	1996-07-02
K960405	SPINAL NEEDLE	Promex, Inc.	1996-02-28
K942442	ACUFEX T-FIX DELIVERY SYSTEM	Acufex Microsurgical, Inc.	1994-12-05
K904380	SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM	Custom Medical Concepts, Inc.	1993-04-08

Legacy Summary#

summary

FDA Review#

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