510(k) K000117

Device: AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
Applicant: AVID MEDICAL, INC.
510(k) number: K000117
Product code: HEE
Decision: Substantially Equivalent (SESE)
Decision date: 2000-04-13
Date received: 2000-01-14
Regulation: 884.5100
Classification name: Set, Anesthesia, Paracervical
Medical specialty: Obstetrics/Gynecology
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: No

Applicant Contact#

Contact: SEAN F SHEMANSKI
Address: 9000 Westmont Dr. Stonehouse Commerce Park Toano VA US 23168 23168

FDA Registration Numbers#

1423507
1224960
1216677
3032109
3010155661
1222993
2245304
3009401905

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HEE #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K052365	CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE	Rocket Medical Plc	2005-10-17
K021224	ENDOCERVICAL BLOCK NEEDLE	Wallach Surgical Devices, Inc.	2002-07-12
K983897	CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G	Ri Mos. S.R.L.	1999-02-01
K980238	GYNEX EXTENDED REACH NEEDLE	Gynex Corp.	1998-08-21
K973671	ENDOCERVICAL BLOCK NEEDLE	A & A Medical, Inc.	1997-11-26
K954718	ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE	Ellman Intl., Inc.	1996-02-29
K910253	LEEP REDIKIT	CooperSurgical, Inc.	1991-04-18
K910252	POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE	CooperSurgical, Inc.	1991-03-04

Legacy Summary#

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