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510(k) K983200

Device
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
Applicant
XIMED/PROSURE/INJECTX
510(k) number
K983200
Product code
GAA  
Decision
Substantially Equivalent (SESE)
Decision date
1998-12-11
Date received
1998-09-14
Regulation
878.4800
Classification name
Needle, Aspiration And Injection, Disposable
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ASHVIN DESAI
Address
2195 Trade Zone Blvd. San Jose CA US 95131 95131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GAA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.2023-03-28
K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap Technologies2011-06-15
K011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.2001-11-16
K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/Injectx2000-03-01
K974741MANAN ACCURA NEEDLEMedical Device Technologies, Inc.1998-01-08
K962425BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)Radi Medical Systems AB1996-09-11
K961959MD TECH BIOPSY SET FOR BONE AND BONE MARROWMedical Device Technologies, Inc.1996-07-19
K945109MONOJECT BONE MARROW BIOPSY TRAYSSherwood Medical Co.1994-11-14
K940025MANAN BONE MARROW HARVEST NEEDLESManan Medical Products, Inc.1994-02-25
K940024MANAN GENERAL PURPOSE INTRODUCER NEEDLEManan Medical Products, Inc.1994-02-25
K930158BONE MARROW BIOPSY PROCEDURE TRAYSymbiosis Corp.1993-07-02
K925621IRRIGATION/ASPIRATION TUBING SETKirwan Surgical Products, Inc.1993-05-07
K924501GILLAM-TUKEL BONE MARROW BIOPSY NEEDLESymbiosis Corp.1993-04-20
K925416SYMBIOSIS BONE MARROW BIOPSY NEEDLESymbiosis Corp.1993-02-23
K922614TURKEL THORACENTESIS SYSTEMSymbiosis Corp.1992-07-30

Legacy Summary#

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FDA Review#

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