Search Results
Found 6 results
510(k) Data Aggregation
K Number
K052365Device Name
CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
Manufacturer
ROCKET MEDICAL PLC
Date Cleared
2005-10-17
(49 days)
Product Code
HEE
Regulation Number
884.5100Why did this record match?
Search-Everything :
Matched: '884.5100'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. This application includes outlines that require local anaesthetics such as loop excision (LEEP), elecro-fulguration, CO2 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies.
For use with 2.2ml glass vials, such as those containing local anaesthetic agents.
Device Description
CerviNeedle™ Disposable Cartridge Syringe
Ask a Question
K Number
K021224Device Name
ENDOCERVICAL BLOCK NEEDLE
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
2002-07-12
(86 days)
Product Code
HEE, FMI
Regulation Number
884.5100Why did this record match?
Search-Everything :
Matched: '884.5100'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, CO2 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.
Device Description
The Wallach Endocervical Block Needle is a Sterile, Disposable, Single Use device. The needle is 27ga., 3 1/2" long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intra-vascular administration set. Over 3 1/4" of its proximal end a 21 gauge metal tube is added to strengthen the shaft.
Ask a Question
K Number
K983897Device Name
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
Manufacturer
RI MOS. S.R.L.
Date Cleared
1999-02-01
(90 days)
Product Code
HEE
Regulation Number
884.5100Why did this record match?
Search-Everything :
Matched: '884.5100'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RI. MOS. Cervical and Intracervical Anaesthesia Needles are used to apply cervical and intracervical anesthesia block.
Device Description
The RI. MOS. s.r.l. cervical and intracervical needles operate with standard medical syringes are are sterile, single-use, disposable devices.
Ask a Question
K Number
K980238Device Name
GYNEX EXTENDED REACH NEEDLE
Manufacturer
GYNEX CORP.
Date Cleared
1998-08-21
(210 days)
Product Code
HEE, 85H
Regulation Number
884.5100Why did this record match?
Search-Everything :
Matched: '884.5100'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Injection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
2. Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.
Device Description
The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.
Ask a Question
K Number
K982097Device Name
WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
Manufacturer
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
Date Cleared
1998-06-25
(10 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Search-Everything :
Matched: '884.5100'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use for the Worldwide Medical Technologies Intracervical Block Needle is to inject anesthetic in the cervical area.
Device Description
Worldwide Medical Technologies Intracervical Block Needle
Ask a Question
K Number
K973671Device Name
ENDOCERVICAL BLOCK NEEDLE
Manufacturer
A & A MEDICAL, INC.
Date Cleared
1997-11-26
(61 days)
Product Code
HEE
Regulation Number
884.5100Why did this record match?
Search-Everything :
Matched: '884.5100'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix Local anesthetics such as electroexcision, electrofulguration, CO2 laser excision and vaporization, and in some patients, endocervical curettage and cervical blopsies
Device Description
The needle is 27g, 3 ½ª long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal lube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intravascular administration set. Over 3 ¼" of its proximal end a 21 gauge metal tube is added to strengthen the shaft
Ask a Question
Page 1 of 1